QA Operations Specialist Job at Bracco Suisse SA in Geneva

To support Quality Assurance Operations activities at the Geneva Manufacturing Site. The role involves ensuring that operations are performed in compliance with current pharmaceutical GMP requirements (EU and US) as well as with the BRACCO Corporate Quality and HSE Management System.

• Batch record review
• Review production batch records
• Release incoming consumables
• Review packaging batch records
• Improve, maintain and ensure a continuous improvement of the following local Quality Systems to ensure the quality of the product
• Ensure that activities related to the sterile production quality are conform with the company policies and Corporate Quality directives. Main contact in case of sterile production deviation
• Lead and manage deviations, including those related to production, maintenance, packaging, and laboratory activities, by driving and coordinating investigations in collaboration with the relevant functions
• Define, implement, and follow up on corrective and preventive actions (CAPA) within the scope of responsibility, ensuring timely execution and effectiveness in line with defined deadlines
• Manage complaints investigation
• Participate to the review and approval of the validation/qualification documentation related to sterile production area
• Ensure the creation, review, and timely update of QA Operations documents
• Review/approve for issuance of GMP documents related to production area (SOP’s, specifications protocols, reports..)
• Participate in and/or lead risk analyses, in collaboration with cross-functional teams
• Participate to change control process
• Auditor in self-inspections and external audits (lead auditor