Beschreibung

To join one of our clients, a growing biopharmaceutical company based in the canton of Vaud. We are looking for a QA Expert for QC who will be responsible for the quality supervision of testing activities and active substance batches, as well as QA supervision of Quality Control (QC) activities within a biotechnological production site based in Switzerland. The position covers batch release, transfers and validation of analytical methods, qualification of equipment, and monitoring of routine tests, in compliance with internal Quality policies, GMP (cGMP), and Swiss, European, and American (FDA) regulations.QA Expert for QCResponsibilitiesActive substances / finished products- Collect and review all documents necessary for the release and shipment of active substance or finished product batches.- Attend weekly release meetings and ensure follow-up of associated performance indicators (KPIs).- Review QC data for active substances / finished products before initial release.- Approve raw materials and reagents used in QC (e.g., standards, controls).- Approve sampling plans.Quality Control (QC) Supervision- Ensure daily QA supervision of QC.- Be the QA point of contact for transfers and validation of analytical methods (review of protocols and reports).- Participate in the drafting, updating, and periodic review of QC SOPs, specifications, and analytical methods.- Be the QA point of contact for OOS, OOT, and Change Controls.- Review and approve stability protocols and reports.- Validate master data entries in the LIMS.- Supervise environmental and utility monitoring programs if necessary.- Be the QA point of contact for scientific department SOPs and equipment qualification.- Support the qualification and commissioning of QC equipment or contribute to risk assessments.- Accompany and train QC personnel on quality compliance aspects.- Contribute to the preparation of annual product reviews (QC section).- Guarantee QA supervision of all quality events related to QC.- Participate in the continuous improvement of the site Quality System.- Support preparation for health authority inspections and act as a subject matter expert in their field.- Interpret and apply GMP, regulatory, and quality system requirements applicable to QC.- Support related QA activities such as receipt of raw materials and suppliers.- Promote understanding and application of GMP among site personnel.- Perform all activities in compliance with internal procedures, regulatory requirements, and safety rules.- Promote a strong culture of Quality, integrity, and ethics in compliance with legal requirements and company guidelines.Profile- Higher education (Bachelor's or university equivalent) in chemical engineering, bioengineering, bioprocesses, pharmacy, chemistry, or biotechnology.- Expertise in microbiology and/or analytical chemistry/biochemistry.- Minimum 5 years of experience in a regulated environment.- Confirmed experience in QA on QC topics; experience in batch release is a plus.- Knowledge of biotechnological processes, QC equipment, and cGMP requirements.- Understanding of regulatory requirements applicable to the production and control of medicines.- Proficiency in quality systems and associated computerized systems.- Experience with health authority inspections desired.- Excellent written and oral communication skills in French and English. jid3302053aen jit0518aen jpiy26aen