Senior Manager Quality Assurance ( Pharmaceutical )

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AURORA GROUPDKI Jakarta

www.jobstreet.co.id

DESKRIPSI PEKERJAAN

Responsibilities:
  • 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
Requirements:
  • 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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Company Description

Aurora EPC is the fastest growing executive placement company in Indonesia, contributing to the growth of organizations by providing them with superior talent in senior and middle management level. Our highly experienced researchers and consultants identify, isolate and evaluate professionals with the skill-set and expertise as per our client’s requirement, while being empowered by our advanced recruiting platforms.