Our client is an active company in the healthcare sector based in Geneva.
- Direct management of operations and packaging QA team.
- Release incoming raw materials and consumables.
- Review batch records (production and packaging).
- Assure the Technical Release of the semi-finished and finished product in compliance to regulations, regulatory dossiers and product specifications.
- Manage all deviations (production, packaging and QC) with the concerned functions.
- Manage complaints investigations.
- Review and approve for issuance of GMP documents related to production area (SOP’s, specifications protocols, reports..), preventive maintenance plan and SOPs and validation/qualification documentation related to production area.
- Ensure that activities related to the product quality and sterile operation quality are conform policies and Corporate Quality directives.
- Coordinate cleaning activities with external contractors.
- Establish compilations and trending of GMP data.
- Participate in audits in self-inspections and external audits.
- Evaluate any signal detection of potential product quality impact and participate to resolve significant quality issues.
- Assure a communication flow and collaboration with operations and other functions to assure a product life-cycle quality.
- backup of QA packaging manager for QA control in packaging.
- Backup of Packaging QA manager.
- Backup in batch record issuance.
- Backup in audit trail review of GMP systems.
- Backup in due date extension for deviations and QA approval of major and critical deviations.
- Backup for QA approval for the following QC lab documentation (lab investigation, lab equipment qualification and calibration).
- University degree in Pharmacy, Chemistry or Biochemistry with 5 to 10 years experience in GMP
- environment inspected by FDA, Swiss and other Health Authorities.
- Fluency in English (both oral and written)
- Quality commitment, flexibility, initiative, problem solving, team working, cross functional
- cooperation behavior.
- Proficient in Trackwise.