Quality Assurance Executive

Job Summary:
To work closely with various functions such as Regulatory Affairs, Pharmacovigilance, Supply Chain, Business Development, Commercial and Finance, as a Senior QA Executive / Regional QA Assistant Manager, to
• Oversee, manage and execute the QA functions/activities,
• Support and implement regional QA projects,
• Ensure compliance to QA regulations.
Job Responsibilities:
Update/maintain the Quality management system compliance of SciGen.
Coordinate and attend external audits/inspections from regulatory bodies or health authorities such as HSA or partners and support QA audits in other regions.
Create, review and maintenance of QA SOPs, WI, forms, reports, SMF, Quality Agreements, etc in the Document Management System (DMS).
In-charge of the DMS and reviewing all other GxP documents.
Track and liaise with contract manufacturers, distributors and partners on product complaints, temperature excursions, deviations and all other quality events.
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