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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.
Ensure 5S, Good Documentation Practice and data integrity principles are implemented at QC Chemical Laboratory area.
Support reviewing testing result for Finished Goods according to lead time.
Requirements :
Fresh graduates or minimum has 1 year experience in Quality Control
Bachelor of Pharmacist 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