- Achieves quality assurance operational objectives by contributing information and analysis to strategic plans and reviews; preparing and completing action plans; implementing production, productivity, quality, and customer-service standards; identifying and resolving problems; completing audits; determining system improvements; implementing change.
- Develops quality assurance plans by conducting hazard analyses; identifying critical control points and preventive measures; establishing critical limits, monitoring procedures, corrective actions, and verification procedures; monitoring inventories.
- Validates quality processes by establishing product specifications and quality attributes; measuring production; documenting evidence; determining operational and performance qualification; writing and updating quality assurance procedures.
- Maintains and improves product quality by completing product, company, system, compliance, and surveillance audits; investigating customer complaints; collaborating with other members of management to develop new product and engineering designs, and manufacturing and training methods.
- Conducts Quality Assurance in-process checks in the Reference Standards Laboratory area as directed by appropriate Standard Operating Procedures
- Candidate must possess at least a Bachelor's Degree, Master's Degree / Post Graduate Degree, Pharmacy/Pharmacology or equivalent.
- A sound knowledge on GMP practices, documentation familiar and exposure with internal audits, external regulatory audits required.
- Have thorough understanding on GMP, GLP, and ISO regulations and the integration of the regulations into working systems in the laboratory.
- Good understanding of the pharmaceutical market, including the unlicensed medicines sector.
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Jl. Boulevard Barat, Kota Jakarta Utara, DKI Jakarta, Indonesia