Beschreibung

We are looking for a Quality Assurance Specialist Biotech. We are seeking a Quality Assurance Specialist to join a biopharmaceutical production site based in the north of the canton. This position covers all production departments and plays a key role in quality supervision, regulatory compliance, and involves close collaboration with production teams and functions. Main Responsibilities Ensure daily quality supervision of production activities (USP, DSP, washing area, media and buffer solutions), including regular presence in classified areas. Carry out reviews of batch records within defined timelines and recommend the disposition of lots, and approve production SOPs to ensure their compliance and effectiveness. Ensure compliance with cGMPs and internal procedures across all activities of documentation management. Review and approve Master Production Records. Examine, approve, and track change controls while escalating issues if necessary. Recommend, approve, and verify the implementation of CAPAs within specified timelines. Guarantee compliance of management activities in production (traceability) and evaluate and approve changes within your scope. Contribute to risk analyses and continuous improvements. Perform GMP tours / GEMBA and ensure follow-up. Represent the QA function during production meetings. Participate in inspections and represent quality assurance during audits and regulatory inspections. Promote Good Manufacturing Practices among site staff. Collaborate with internal stakeholders to ensure effective processes. Interpret applicable regulatory requirements and ensure their implementation. Keep regulatory knowledge up to date and contribute to the Quality culture within all policies, procedures, and safety requirements. Your Profile: Degree in scientific or applied sciences (pharmacy, chemistry, biotechnology, engineering). Minimum of 2 to 5 years of experience in Quality Assurance within a pharmaceutical or biotechnological site. Excellent understanding of cGMPs and regulatory requirements for biotechnological processes (USP / DSP). Experience in managing inspections or audits. Strong analytical and problem-solving skills, clear and structured in both oral and written communications. Fluency in French (oral and written). Knowledge of English is a plus. jid8bb7469aen jit0206aen jpiy26aen