# data[].attributes.body
thanks Galvin for helping to take care of Michelle (student from Duman high). i believe she gain experience from you! thanks for spending a day with her, showing her what is a day like being a OQ!
Shirley Ten

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Thanks, Kenneth, for ur great help and last min kana pull by me to support the recall simulation!! really appreciate that to save me!! :)
Shirley Ten

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Thanks for helping me to cover shift QO matters while i was away on long holiday!
-Galvin

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Thank you Shirley and Irene for helping to support Q3 ATR with team 3!

Thank you Felicia and Hazel in your efforts to ensure the QTR is issued timely despite a very busy month with PPR issuance and self inspection!

Thank you Esther for reviewing the QTR report and providing your comments and guidance on the report write up

Thank you Jerlene for the helping to borrow and manage all the LWS (:

- Rui Xin

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For guiding me to advice when ASO engaged me on a PMC UC on HPL_IC on Monday (though I am still not OJT trained yet). and Esther for sharing the thought process in UC Part B assessment and consideration on it.

And subsequently another UC also on PMC for ICP equipment on Thursday.

Hang in there, while I get myself trained after PPR issuance and in the month of Dec-22!

|Felicia|

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Thanks Robelyn for giving the quality steer and following thru Nara UC (over the weekend) and its remedial actions (NRA) to ensure PB3 can resume Nara manufacture.

Shirley Ten

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thanks ladies for being adaptable to the needs of production for doc error new WOW from listening to them to prepare slide pack and working with them. i believe we can help them to make the change together!

Shirley Ten

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thanks donald for supporting the plant tour for QR folks! I believe they must have learn alot from you :D

Shirley Ten

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Thank you both for being so understanding and making plans to switch the shift rotations around so that I can WFH and be at home to take care of my wife (Covid 19 +) given my circumstances.

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For taking the leadership and initiatives to support Team 2 when the IPA OOS matter was escalated. In addition to providing support as an OQ rep, you have also provided the leadership to provide clarity to both P&L and VS1 on what needs to be done to move forward to enable the use of IPA for Dol campaign.

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For Doing the Right Thing and also being Accountable for Impact whereby you have followed up (though tedious) on the half yearly defect Kaizen following the SQC presentation. You are following up on the comments given by the SQC and through this, you are ensuring that the actions taken as a follow up from the Kaizen would be meaningful for the site to reduce defect rate.

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Thank you to Esther, David, Kenneth, Galvin, and Kee Jun 

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Thank you to Esther, David, Kenneth, Galvin, and Kee Jun 

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You have demonstrated what Accountable for Impact really means to all of us. As a team, you have prioritised on the IPA OOS investigation due to its impact on business (Dol campaign). The prioritisation helps P&L and VS1 have the QA steer on what needs to be done so that we do what matters to quality with minimal impact to business timeline and compliance to GMP requirement.
Thank you!

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Thanks for helping team 1 to approve a temp BSA on last wed when nobody is around.

Shirley Ten

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Thanks for supporting the change control for the 1kg of Dol API discrepancy to allow Ware to able to GR the micronised API batches by this week while I was conducting audit last week and out of office this week.
- Lay Hoon

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Thanks to Felicia helping with VS1 tier while I was conducting internal audits last week.
Will need to trouble you and KJ to attend the tier for the next 2 weeks.
- Lay Hoon

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Thanks everyone for the inputs and the brainstorming session for OQ strategy day! Lets hope that these pain points identified can be removed and making our working life more enjoyable next year!
- Esther

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Thank you Galvin for coming back on Friday night to verify transcription of swab results onto Cabo2 dismantling logsheet due to the urgency to release the vessel train for the next process!! - Robelyn

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Thanks Hazel for fronting cFP PPR and preparing the topic since the first issuance. She didnt author any of CFP PPR but able to pick up quickly and paid addition effort to understand the list of changes on the listing.
- Esther

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Thank you both for working overtime to help out with the listing for cFP as a sudden request on the additional scope for inspection! Despite the last minute notice, we able to finalise the meeting with additional fields before the agreed timeline of 8pm! Thank you very much!
- Esther

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for taking the helm to coordinate the quality matters when the FDA audit shifted focus to CFP! KJ

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for supporting and working with VS1 for the LAM PSD DE and ensure timely closure! KJ

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for supporting and working with VS1 for the customer complaint report for Dolute weight discrepancy and ensure timely closure! KJ

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who had the honour to front topics to FDA! Everyone was well prepared and spoke confidently and helped put the Investigator at ease for the entire audit! KJ

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Thanks for closing the 4-phenylbutanol OOS DE while I was working on the SQC slides.
- LH

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for supporting the next cycle of Intern interviews and taking over the Intern chair! #Teamwork KJ

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for scheduling all the audit rehearsal sessions for OQ! #Teamwork KJ

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for supporting a CAPA (review 3 change controls post SOP upversion) that was assigned to Xu Min! #Teamwork KJ

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for your support on the Dol 3 decon black specs issue and specially returning to site to review and approve the INI on the same day of detection to allow Dol shipment to proceed! #Accountability KJ

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Thanks Hazel for working late on the Mylan PRS with the supplier and Kai Shih for multiple calls to address all the comments from both Japan LOC and Mylan. We managed to resolve most of it; however we also discover a regulatory conformance gap. Bumpy road ahead but we are on the right track doing the right thing! #Accountable!

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Congrats Wilson for passing your OJT for plant inspection and release. I also want to thank Donald and Kenneth for helping to be trainer and assessor. Thanks all for your team work!
Shirley

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Being the new lead supporting team 3!! It was a busy and very exciting first month! Thank you for helping to provide your guidance and the work allocation with the audit and business needs.
-Hazel and team 3 :D

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Thanks to Jerlene, Rui Xin and Felicia!!!

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Thanks to Jerlene, Rui Xin and Felicia!!!

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Last but not least, thanks the team for able to generate the listing for GMP Listing last minute as the task was not tracked due to the multiple handovers we had! However, we still manage to deliver within the new due date despite the many other routines we were juggling! So good job to the efficiency of the team!

Special mention to Jerlene for completing her first task for Team 3 as well! Thank you!

Hope the steam continues as we prepare for FDA with longer review period heh..

- Esther

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Loads of appreciation for Hazel for being accountable as SME for completing the reduced testing qualification for hazardous materials, for TTS to compile and review the IQA as part of TTS simplification project, fronting audit as SME for PHI PPR at the same time handling both Japan LOC and Mylan to revise the PRS for Mylan Outsource Lam!!

Past few weeks were not easy for her as she need to manage multiple due dates and different stakeholders in order to get the tasks completed in time!

But many kudos for her endurance and her can-do attitude that still manage to deliver to her best capability despite the many late OTs she had to do!

- Esther

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Thanks Felicia for the last minute request of supplier complaints listing requested by Visu for the RIC Hot Topics Identification!

This listing is not identified initially during the Pre-PAI audit meeting. It was requested last two days before the start of audit. Thus, load of thanks to Felicia still able to complete them within the short timeline given!

- Esther

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Appreciate dedication of Rui Xin despite being on MC, she helped to follow up with the TTS with Aranda to ensure we meet the shipment for end Aug and also the signing off of PRS to address the storage and transport condition gap prior to RIC Audit!

- Esther

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Loads of thanks to Lay Hoon and Kenneth and Kee Jun

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Loads of thanks to Lay Hoon and Kenneth and Kee Jun

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Thanks Lay Hoon and Kenneth for the amazing team work and engagement in multiple teams call  in getting the DCM drum from JPP reassigned to our GMP code. This allows the batch to be re-assigned so that it can be sampled and tested before decon use planned today (25-Jul-22).

Lay Hoon contributed by imparting her knowledge and experience with this rare reassignment of input raw material with different UoM.

Kenneth for helping with the speedy change to UD and reassignment of the batch while I am wfh.

Not forgetting Kee Jun for helping to show where sampling report spool might be hidden as we were having problem locating where the sampling report is printed, else re-print will be required.

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For guiding me through, my 1st OQ monday tier even though I have attended maybe twice and still unfamiliar with the flow of events.
Felicia

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Thank you Shirley for sending out the urgent request  and multiple chasers to Novartis for the MEK8 memo.

-Kenneth

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for working tirelessly on the 2 major DEs (H2S and FP Stability KF) and closing them after office hours.

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Thanks Kenneth for the last minute work to re-do the MEK DSOP to provide the clarity to Customers and giving them the assurance that there is no impact.
Thanks Shirley for driving NVS to issue the memo for market restriction and batch details.

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for your out of office hour support on the challenging PB1 UC for the bellow pin holes and ensuring we do the right thing.

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Thank you Galvin, Kee Jun, Lay Hoon, Shirley, Esther, Yu Ding, and Hanim for supporting Susan & Andy's visit 

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Thank you Galvin, Kee Jun, Lay Hoon, Shirley, Esther, Yu Ding, and Hanim for supporting Susan & Andy's visit 

# data[].attributes.body
Appreciate the best efforts invested into preparing for the presentation. While some were not presented and I was disappointed as the team has put a lot of efforts, I personally learnt a lot from the process whereby we learnt what is important and impactful for the site and we can use this learning to help us focus on the impactful processes for the site too to make Quality as a Competitive Advantage. And, let's look out for what else are our ASKs from next visitors.

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Appreciating Esther, Lay Hoon, Hazel, Felicia, and Rui Xin

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Appreciating Esther, Lay Hoon, Hazel, Felicia, and Rui Xin

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Thank you Esther for your leadership for being Accountable for Impact and ensuring that the PPRs are timely issued despite the changes that the team is going through. Appreciate Hazel, Lay Hoon, Rui Xin, and Felicia for the energy and dedication to get the PPRs done timely and engaging the various stakeholders including new ones.
Lorraine

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Really appreciate the support, dedication, and good work that you have provided to close the investigations that were due last week. These were the H2S investigation at PB3, the FP Stability investigation (DE + LI), and the Lam Flow control valve investigations. Appreciate that you followed up after working hours to ensure MERP txn were followed through. Thank you for being Accountable for Impact and ensuring that we continue to Do the Right Thing. - Lorraine

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Thanks Hazel for preparing for audit rehearsal for both PPR and Reduced Testing topics! Although we don't have time to go through the second topic, credit to her to complete the overview slides pack from scratch!

Definitely more to prepare for the MFQs but we will get more confident from there~

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Thank you Jia Jing for taking initiative and for being an excellent team mate during your stay in Team 1! And for also helping with the inspections whenever you can :) See you around! - Robelyn

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for your support in Hanim's and Xu Min's absences last week! LKJ

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Thanks Jia Jing for tanking my Deviation investigation and your CI sharing on how to manage document review for thick records. Thanks alot and see you around !!!

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Thanks Jia Jing for tanking my Deviation investigation and your CI sharing on how to manage document review for thick records. Thanks alot and see you around !!!

# data[].attributes.body
Wilson

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Hi Jia Jing :

I would like to send my appreciation to you.

For pass few months you’ve contributed great efforts to OQ team 1 in overcome the back log for our routine works. In additional also like to say thanks for last week CI sharing on how to deal with the many pages of document reviewing process. This will truly improve to our working efficiency and increase the productivity for us to do more ! Thanks a lot ! Donald Cheong

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Appreciate Donald for tanking the SG9 inspection for vessel and the isolator. 6 hours in the 'hot suit' is not easy and you still managed to do it for the team.
- Galvin

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Thanks Jia Jing! I really want to thank u for being part of my team! This 6 mths u are competent in all the team 1 ojt, and has been a great help to us. I like your can do attitude and never reject my request. Its sad that your interest is in engineering and not quality, else we will like to have you in our team . You will definitely do well in engineering! Keep in touch ya!

Shirley

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Thanks Jia Jing for your hard work and taking on the challenge to improve OQ processes. You have been quick to understand quality concepts and managed to adapt to shift work. Appreciate your initiative and efforts to support the workload as well! See you around! -Kenneth

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Appreciation and Farewell post to Jia Jing!

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Appreciation and Farewell post to Jia Jing!

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Thank you for being part of OQ and also being Part of Team 1's member! We really appreciate the contributions you have made during your stint in OQ, from easing off the pressure of batch record review to helping us ensure our ATSP is met weekly! I believe we couldn't have managed that well without your help and support and I also believe all the other members feel that way too!

Hoping that the takeaways from your short stint here will helped you in your future role in Engineering, we also hope that you will fly and shine in your future endeavors!

- Team 1

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Thank for your help on sharing of GSK benefits for QD L&L! I'm sure it would benefit everyone who has attended on how to maximise the GSK coverage!

Yu Ding

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Approving PSR from Logisitics on Friday night 10pm to ensure that the PSR is issued on time and ensure no overdue PxR!

Yu Ding

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for supporting one another as Xu Min is on leave. also want to appreciate kenneth for quickly picking up the CCAs from Xu Min. LKJ

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thanks to both of you for working hard to close the DE assigned to you both and ensuring we found the root cause and doing the right CAPA!
Shirley

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well done team to enable the full release of Cabo despite BC has an LI!

Shirley

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Appreciate Robelyn and Jia Jing for helping to follow-up with the FP 6 DBFA closely and also Outsourced Matters when I was on off-rest. Depsite the heavy workload, both of them have helped to prioritise these matters to ensure that matters run smoothly.

Appreciating Team 1 to help cover for my absence during my reservist. As kenneth has moved from Team 1 to Team 2, all of them have helped to take on some of the extra workload on top of the existing ones! Without the help from you guys, I wouldn't be at ease to concentrate fully on my reservist. Big thanks to you all!

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Appreciation to Reina for rendering help at the very last minute to create timemap for the FP06 KF stability issue. Request arises from LIC meeting in which the panel suggest for a timemap representation in the slide deck which needs to be issued on the day itself. Reina is quick to grasp and  understand the team's request, provide timely update for feedback and comments  and is able to deliver before she boards the bus at 5pm on 02-Jun-22. She has also helped with creation of scatterplots that feed into the slide deck.

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for the hard work put into the FP stability matter! lkj

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for being the anchor for Team 2 and managing the various issues in my absence! lkj

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for helping to chair the daily OQ tier for almost the whole week! lkj

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for helping with the UC and INI DE for VS3 overdue CAPA as I am tied down with L2 audit and Hanim with FP stability matters and another 4 UCs and 3 DE INI due around the same time. LKJ

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for helping to retrieve SG9 stability proforma over the weekend to support JNDA submissions.
- Lay Hoon

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For supporting Monday tier scribe as Eugene's replacement! LKJ

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for supporting Kenneth in his INI for the different interpretations of DSOP26. LKJ

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for the courage to tell Evreux that we are not raising a customer complaint for hole in bag in view that it happened after batch was sampled at their end. LKJ

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Thank you Reina for helping with the execution of the DSOP CI project, from tidying up the data, engaging scheduler and planners and to draft the presentation slides. She had put in multiple effort in making the piece of work coming together and for the benefit of the stakeholders. Good job! hope you learn something!

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Thank you Esther for standing in and managing some of the UC under JPP for the past few weeks :) - Eugene

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Thank you for helping me to organize the plant walk within OQ team and follow up with the agenda so closely! Hope we have all gained more knowledge about the plant and operation! - Xu Min

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Thank you Hazel and Hanim for your time over the last few weeks as we were discussing on the reduced testing and MQ matters for hazardous materials. We have identified a way forward and some improvements to be made :) - Eugene

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Thank you for demonstrating accountability to lead the OQ team going on for a plant walk! Thanks to your proactive engagement of the production superintendent and production manager, we were able to complete the walk with considerable number of ZIP/ZAP! More importantly, we get to know the plant better! - Xu Min

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Thanks Kee Jun for taking time to discuss with me on your views and providing directions on a few supplier related change controls and future MQ plans!  - Eugene

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Thank you Xu Min for helping up with the review and signage of Cabotegravir Shipment declaration form to Upper Providence! This has allowed material to be exported timely based on schedule to support R&D evaluation. - Eugene

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Thanks Kee Jun for supporting the DBFA deviation since INI to final DIR.
From reviewing the DIR, attending DE clinic to the discussion of batch tying.

Thanks Yu Ding for offline review and guidance on the DIR.

Thanks Kenneth, Galvin and Shirley for supporting the 2021 DBFA input. Looking forward to the gemba to explore for any improvement on the DBFA and batch release process as we may have DBFA with different scenario (routine and validation) in the future. :)

-Lay Hoon

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I want to dedicate an individual post to Thank You! Because you have help me to do the background work on checking the ASL against the supplier audit reports and adjusted the ASL into the new look. And now we have to prepare for the migration of manufacturers' addresses into QIR after I issue the migration protocol. Just want to acknowledge your contribution that help to embed the benefits into the system. - JK

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Thank you Team 2 and Team 3 for the ASL Simplification & e-QIR form!

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Thank you Team 2 and Team 3 for the ASL Simplification & e-QIR form!

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Thank you Team 1 & 2 for attending and providing yr valuable feedback on the 2 Gemba sessions on this initiative.

Also want to thank my fellow Team 3 for supporting this improvement by giving your most thoughtful considerations, ideas and suggestions as we progressed and now we've agreed on the new WoWs on the ASL and QIR form. Hope we have understand the benefits better and will feel easier when we manage future manufacturers' addresses changes. This is also for the P&L & Lab users to make their checks easier during GR. Just want to acknowledge this is a team effort. Thank you! - JK

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For setting up session with Team 3 to discuss on areas for improving communications between Team 2 and 3

Yu Ding

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Thank You Jen Kaen, Lay Hoon, Rui Xin and Reina

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Thank You Jen Kaen, Lay Hoon, Rui Xin and Reina

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For the GEMBA with VS1 engineer on the management of statistical tare weight that would be incorporated in the LSOP. Our inputs would help VS to better shape the approach!

Yu Ding

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Thanks Team 2 for covering me during my absence so that I can have a peace of mind to enjoy my leave!!

#teamworkrocks!
- Esther

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Appreciate your advice for my queries on the change control assessments for N2 new plant and allowing MSA99 for LTR. Thank you for always standing firmly at our back and providing your strongest support to enable us make the right decision! - Xu Min

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Thank you Reina for supporting me to perform verification of training attendance for Management of Deviation in MERP course. Despite my very last minute request and little guidance provided, you were able to complete the task swiftly! Your effort has ensured that the attendance is only recorded for learners who attended the training! - Xu Min

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For your QA steer and support for the last minute N2 plant supplier change that impacts N2 usage for the entire site! LKJ

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For working tirelessly to close up the customer complaint for hole in bag with no further comments from Evreux! LKJ

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For supporting an urgent MC extension in Esther's absence!

LKJ

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thanks team 1 - for consistently work hard, accountable for impact in ensuring batch release target it met! i really appreciate the effort that you guys put in! - Shirley

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thanks Kee Jun and Robelyn for being involve with the THF and HCL issue for PHI with PP. there were a fair bit of difficult conversion but i am glad that with your support, we manage to resolve the issue with PP - Shirley

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congrats to Jia Jing on passing batch release OJT a few weeks ago and he will be clearing plant inspection and release next! - Shirley

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thanks Donald for going to PB3 for plant inspection and have positive findings. this delights the pb3 team. although, there is room for improvement from the safety perspective. remember to raise ZAP to boost our count! - Shirley

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when i was reviewing Robelyn's taxi expense, i noticed she claim lesser than the receipt amt, after clarifying with her, she mentioned that she deducted the amt as the grab driver's car broke down and the amt was reimbursed. this is actually not obvious in the receipt but nonetheless, she is honest and doing the right thing! - Shirley

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for supporting a UC on SG9 post val batch as Hanim is engaged for L2 audit. LKJ

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Thanks for helping to retrieve 22 batch release forms for the DBFA batches so that we can proceed with the next step of the deviation investigation.
- Lay Hoon

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Thank you Team 3 for supporting each other on the work to ensure timelines are met while I was on reservist for the past week!

Yu Ding

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Thank you for spending time to extract the change control details for MSA99 in MERP2 and spend time to go through the MQ background with me! # Accountability and Teamwork! - Xu Min

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Thanks to the QOs and line managers for completing and approving the CI for Q1. Keep it up!
If you couldn't manage to complete or approve it for Q1, it's okay! We still have 3 more quarters to catch up! Jia you everyone (including myself) :)
- Lay Hoon

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Thanks for following up QR PxR CAPA with Puay Boon and typical limit report for MEK for another CAPA while you were sick last week.
- Lay Hoon

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Thank you Lay Hoon for picking up my phone call and messages to allow me to learn about the background on initial reduced testing on SG9 New Materials so that I can figure out what is applicable for Zejula!
-Esther

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Thanks for changing your shift to support to shipment of SG9 to Millipore Sigma
- Lay Hoon

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for supporting the BFM weight discrepancy Supplier Complaint + issuing Form A + comms to Supplier in Xu Min's absence! LKJ