QA Manager (Pharma)

To complete the Quality Assurance & Quality Control department of an international company leader in the pharma sector, we are looking for an

Technical Operations Quality Manager

You will be in charge of the Operation Quality Assurance in the Manufacturing Site.

Activities

• You will be in charge of releasing the incoming raw materials and consumable;
• You will be responsible for the batch records (production and packaging) reviewing;
• You will assure the Technical Release of the semi-finished and finished product in compliance to applicable regulations, regulatory dossiers and product specifications;
• You will manage all deviations (production, packaging and QC) and complaints investigation;
• You will Review/approve for issuance of GMP documents related to production area, preventive maintenance plan, SOPs and validation/qualification documentation related to production area;
• You will ensure that activities related to the product quality and sterile operation quality are conform with the company policies and Corporate Quality directives;
• You establish compilations and trending of GMP data;
• You evaluate any signal detection which could have a potential product quality impact;
• You will manage directly the operation and packaging QA team.

Your profile

• You have a University degree in Pharmacy, Chemistry or Biochemistry with 5 to 10 years experience in GMP environment inspected by FDA, Swiss and other Health Authorities.
• You are fluent in English (both oral and written).
• You have an experience of 5 years as manager.