Description
To join one of our clients, a rapidly growing biopharmaceutical company based in the canton of Vaud. We are looking for a Senior QA Specialist – QC Oversight who will be responsible for quality oversight of testing and release activities of active substance batches, as well as QA oversight of Quality Control (QC) activities within a biotechnological production site located in the northern part of the canton of Vaud.
The position covers batch release preparation, analytical method transfers and validations, laboratory equipment qualification, and routine test monitoring, in compliance with internal Quality policies, GMP (cGMP), and Swiss, European, and American (FDA) regulations.
Senior QA Specialist QC Oversight Biopharma
Main Responsibilities
Release of Active Substances / Finished Products
- Collect and review all documents necessary for the release and shipment of active substance or finished product batches.
- Lead weekly release meetings and monitor associated performance indicators (KPIs).
- Review QC data of active substances / finished products prior to release.
- Release raw materials and reagents used in QC (e.g. standards, controls).
- Approve sampling plans.
Quality Control (QC) Supervision
- Ensure daily QA supervision of the QC laboratory.
- Be the QA referent for method transfers and validations (approval of protocols and reports).
- Participate in drafting, updating, and periodic review of laboratory SOPs.
- Approve specifications and analytical methods.
- Be the QA contact point for deviations, OOS, OOT, and Change Controls.
- Review and approve stability protocols and reports.
- Validate master data changes in the LIMS.
- Supervise environmental monitoring and utilities programmes if necessary.
- Be the QA referent for scientific department SOPs and equipment qualification.
- Support qualification and commissioning of laboratory equipment.
- Lead or contribute to risk assessments.
- Support and train QC staff on quality compliance aspects.
- Contribute to the preparation of annual product reviews (QC part).
- Ensure QA oversight of all quality events related to QC.
- Participate in continuous improvement of the site Quality System.
- Support preparation for health authority inspections and act as a technical expert in the field.
- Interpret and apply GMP, regulatory, and quality system requirements applicable to QC.
- Support related QA activities such as raw material reception and supplier evaluations.
- Promote understanding and application of GMP among site employees.
- Perform all activities in compliance with internal procedures, regulatory requirements, and safety rules.
- Promote a strong culture of Quality, integrity, and ethics.
- Act in compliance with legal requirements and internal guidelines.
Profile Sought
- Higher education (Bachelor 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 GMP environment.
- Proven experience in QA on QC topics; experience in batch release is an asset.
- Strong knowledge of biotechnological processes, laboratory equipment, and cGMP/cGDP requirements.
- Good understanding of international regulatory requirements applicable to pharmaceutical manufacturing and control.
- Mastery of quality systems and associated computerized systems.
- Experience with health authority inspections is desirable.
- Excellent written and oral communication skills in French and English.