On the Global Manufacturing and Supply (GMS) team at Takeda, you’ll be part of a rapidly transforming industry that’s applying technology and data in new ways. Within our agile, innovative, people-centric organization, your work will matter every day as you use your skills to help us manufacture therapies for patients on our four platforms:
- Small Molecules
- Biologics
- Plasma
- Cell and Gene
As part of the GMS team, you'll have the opportunity to pursue unique experiences and build new skills, and you'll know that the work you do every day makes an impact — on our patients, our people, our planet, and on yourself.
I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda’s Privacy Noticeand Terms of Use. I further attest that all information I submit in my employment application is true to the best of my knowledge.
Job Description
Duties & Responsibilities
:
Responsible as coordinator of stability study activities of finished product, including creating stability protocol, sample request, product sampling from chamber, review testing report, creating stability report, archiving stability study testing report, and monitoring of stability chamber and stability room.
Responsible as Lead Investigator for Laboratory Event and Deviation.
Self-inspection coordinator for QC chemical lab.
Support PQR completion by providing stability data and evaluation as required.
Support qualification activities of new QC Equipment/ Instrument (support AIQ/CSV).
Ensure availability of reagenVconsumable/RS/WS for testing purposes as well as its compliance.
Ensure temperature monitoring in Chemical QC Lab and conduct instrument data backup ex. Manual back up, log tag etc.
Perform relevant Global SOP Gap Assessment, creating new or revise SOP, perform SOP periodic review at site.
Ensure5S,GoodDocumentationPracticeanddataintegrityprinciplesareimplementedatQCChemicalLaboratoryarea.
Support reviewing testing result for Finished Goods according to lead time.
Requirements :
Fresh graduates or minimum has 1 year experience in Quality Control
Bachelor ofPharmacist or any relevant major
Good understanding about GMP and GLP
Have necessary laboratory skills, including knowledge of how to perform analytical chemistry, instrumental analysis and physical chemistry
Good English competency (reading, listening and speaking)
Proficient in MS Word, Excel and PowerPoint
