Beschreibung

Senior QA Specialist QC Oversight BiopharmaTo join one of our clients, a growing biopharmaceutical company based in the canton of Vaud. We are looking for a Senior QA Specialist – QC Oversight who will be responsible for the quality oversight of testing activities and active substance batches, as well as QA oversight of Quality Control (QC) activities within a biotechnological production site based in the north of the canton. The position covers the release of batches, 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.Senior QA Specialist QC Oversight BiopharmaResponsibilitiesRelease of active 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 release.- Approve raw materials and reagents used in QC (e.g., standards, controls).- Approve sampling plans.Quality Control (QC) Oversight- Ensure daily QA oversight of QC.- Be the QA point of contact for transfers and validation of 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 the entry of master data 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 drafting of annual product reviews (QC section).- Guarantee QA oversight 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 raw material receipt 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.- Proven 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 production and quality control.- Mastery of quality systems and associated computer systems.- Experience with health authority inspections desired.- Excellent written and oral communication skills in French and English. jid343e815aen jit0624aen jpiy26aen