Quality Assurance Manager
– Ensure production activities comply with GMP and comply with government regulations.
– Ensuring that products when releasing will meet the registered quality criteria
– Monitor risk management activities
– Deviation handling and Quality Risk Management
– Establish training plan and implement GMP training, training new processes.
– Perform data integrity
– Remediation plan for Validation activities (All equipment qualified, Packaging Validation, Cleaning Validation Transport, Validation, CSV.
– Controlling the implementation of CAPA, the following evaluation completes CAPA
– Completion CAPA plan on time
– Planning audit of active ingredients, packaging, … at the manufacturing site
– Perform quality contracts with active suppliers
– Approval of the internal inspection plan – Performs internal inspection
– Performs GMP inspections (WHO, EU,…)
– Some things are authorized from the General Director: such as approving drug registration documents
– Develop, manage implement, communicate, and maintain a quality plan to bring the Company’s Quality Assurance Systems and Policies into compliance with quality system requirements
– Final decision on the release or rejection of pharmaceutical products
– Verification of compliance of products with registration dossier requirements
– Bachelor’s degree of Pharmacy
– At least 5 years’ experience working in a QA position in the Pharmaceutical factory.
– At least 2 years of quality system management
– Ability to analyze and solve problems
– Ability to work under high pressure and intensive deadlines
– Understand the systematic process of GMP-WHO, GMP-EU in the pharmaceutical industry.
Lot M7A, D17 street, My Phuoc 1, Thoi Hoa, Ben Cat, Binh Duong
For more information please email to firstname.lastname@example.org with the email title: “Quality Assurance Manager”.