Our client is one of the top global pharmaceutical companies. This position is responsible for being an integral quality member of the Regulatory Affairs & Quality Assurance Team.
Provide Quality oversight for manufacturing partners and distributors and advise on policies and procedures regarding quality assurance.
Contribute to the interpretation of GMPs and GDPs for functional areas.
Support authoring of Quality Assurance Agreements with alliance partners and distributors
Communicate with and influence internal and external customers across site to ensure compliant and aligned resolution of quality related issues and investigations
Review and approves various GMP and GDP documents including batch records, protocols/reports, investigations, change controls, period of use, dosing and administration instructions, product specifications, etc.
Facilitate the overseas Quality Audit team and ensure the smooth communication between the audit team and the manufacturing partners regarding quality and compliance matters.
Bachelor’s degrees in pharmacy
Minimum 7 years experience in QA functions in pharmaceutical industry
Strong knowledge in GMPs, GDPs, and CMO
Good command of English