Description

As part of strengthening its activities, a biotechnology company based in the Vaud region is looking for a QA QC Expert to ensure quality supervision of quality control (QC) activities and drug substance and drug product batches. You will play a key role in ensuring compliance with QC requirements.Your responsibilities:- Collect and review all necessary data for batch release (DS/DP).- Participate in and lead weekly disposition meetings.- Review QC data for incoming, standards, and QC reagents.- Approve sampling plans.- Provide QA oversight of QC activities.- Ensure daily quality supervision of QC.- Serve as the QA reference for method and analytical transfers.- Approve protocols, reports, and analytical methods.- Manage OOS/OOT and Change Controls related to QC.- Participate in the drafting and review of QC SOPs.- Approve stability protocols and reports.- Supervise environmental monitoring and utilities programs if necessary.- Contribute to the continuous improvement of equipment & processes.- Participate in risk analyses and compliance discussions within the QC teams.- Contribute to Annual Product Reviews (QC part).- Ensure support during regulatory inspections.- Participate in cross-functional QA activities (vendors, incoming goods, fostering a strong quality culture and good GMP).Your profile:- Scientific background (Chemical Engineering, Biotechnology, Pharmacy, Chemistry or equivalent).- Minimum 5 years of experience in a GMP environment.- Proven experience in QA within QC activities (release experience is a plus).- Good knowledge of biotech processes and regulatory requirements (cGMP, FDA, EU, Swiss).- Experience with health authorities' inspections.- Comfortable with quality systems and tools (e.g., LIMS).- Ability to make compliant decisions.- Excellent communication and team spirit.- Fluent in French and English is essential. jid4e52ff0aen jit0414aen jpiy26aen