QA / QC Specialist – GMP Environment (Lausanne)

About the role

Join GXP Consulting Switzerland as a QA / QC Specialist and contribute to high‑quality pharmaceutical manufacturing in the Lausanne area. You will work in a GxP environment, ensuring product safety and regulatory compliance while supporting continuous improvement initiatives.

Key responsibilities

• Manage deviations, CAPAs, change controls and follow‑up escalation processes.
• Review batch records for product release and support QC/QA transfers of new products and methods.
• Participate in internal audits and regulatory inspections (EMA, FDA) and provide GMP training to staff.
• Write, update and validate SOPs, quality documentation, and handle qualification/validation activities (DQ, IQ, OQ, PQ, cleaning and process validation).
• Perform or supervise physico‑chemical and microbiological testing, monitor stability studies, and oversee laboratory equipment qualification, maintenance and calibration.
• Develop, validate and transfer analytical methods, writing protocols and reports as required.

Required profile

• Minimum 3 years of QA/QC experience in a GMP‑regulated pharma or biotech company.
• Master’s degree (or equivalent) in Life Sciences or a related discipline.
• Strong knowledge of cGMP, Eudralex, GLP and FDA 21 CFR requirements.
• Excellent written and oral communication skills in English and French.
• Analytical, organized, with solid problem‑solving abilities.

Required skills

• GMP / cGMP
• Eudralex, GLP, FDA 21 CFR
• Deviation management, CAPA, change control
• Validation (DQ, IQ, OQ, PQ), cleaning validation, process validation
• Analytical method development, validation and transfer
• Stability study monitoring
• Laboratory equipment qualification, maintenance, calibration
• Physico‑chemical testing, microbiological testing

What we offer

• Opportunity to impact patient safety through high‑impact quality work.
• Collaborative, multicultural environment with continuous learning opportunities.
• Competitive salary package and comprehensive employee benefits.