Description

As part of its growth, an innovative biotech company from the north of Vaud is seeking a Compliance Senior Technician / Specialist to strengthen its compliance pillar. You will intervene at the heart of operations to ensure adherence to cGMP requirements, actively contributing to continuous improvement.Compliance Senior Technician / SpecialistYour responsibilities:- Ensure a consistent level of compliance for Manufacturing activities in preparation for inspections.- Manage compliance tasks from A to Z (opening, closing on time).- Define, lead, and monitor CAPA and their effectiveness.- Manage Change Controls (compliance and continuous).- Participate in the design, review, and release of MBR records.- Perform batch record reviews (exception reviews).- Define and monitor quality and performance KPIs as a SME.- Prepare for health authority inspections.- Write, review, and approve SOPs/WIs and production documents.- Train and support USP/DSP teams on GMP requirements.- Identify and propose continuous improvements (process, equipment), closely with QA teams to deploy quality.- Promote a strong culture of compliance, ethics, and integrity.Your profile:- BSc, Master’s or Engineer in biotech/pharma.- Minimum 3 to 5 years of experience in a biotech cGMP environment.- Solid experience in CAPA/Change Control and root cause analysis (type FMEA, quality tools).- Good understanding of USP/DSP environments.- Comfortable in a dynamic, demanding, and highly regulated environment.- Fluent in French and English.- Team spirit, autonomy, and ability to take initiative. jidfb29babaen jit0414aen jpiy26aen