Quality Assurance Executive

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, devi...