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.