Description

To join one of our clients, a growing biopharmaceutical company based in the canton of Vaud. We are looking for a QC Compliance Specialist to join a biotechnological production site based in the north of the canton. The QC Compliance Specialist ensures the compliance of QC activities with applicable regulatory requirements, internal company standards, cGMP requirements, and site procedures. The position also contributes to the continuous improvement of QC compliance processes according to industry best practices. The main responsibilities include the management of change controls, CAPA, data integrity, the validation and maintenance of analytical software, periodic reviews, support for inspections/audits, regulatory and pharmacopeial monitoring, monitoring of quality indicators, management of QC consumables and samples, as well as training activities.Main Responsibilities- Act as a QC compliance expert and support QC teams on quality and compliance topics.- Manage, document, investigate, and close QC quality events in collaboration with subject matter experts.- Ensure the effective and timely processing of change controls, CAPA, and periodic reviews.- Coordinate the execution of the QC Data Integrity plan, including risk analyses, action plans, risk escalation, and reporting.- Strengthen the Data Integrity culture within QC via risk assessments and training needs analysis.- Perform periodic reviews of QC equipment and associated systems.- Participate in the qualification of new QC equipment and associated software (URS, risk analyses, protocols, and reports).- Provide support for the management of QC samples from production: reception, aliquoting, registration in the LIMS.- Follow equipment work orders and review associated documentation (calibration, preventive maintenance, technical interventions).- Participate in QC training activities according to approved procedures.- Perform certain compliance activities in the LIMS (QC reviews, equipment status changes).- Perform monthly reviews of environmental alarms for the QC department and ensure follow-up of associated actions.- Write, review, approve, and maintain SOPs, work instructions, and quality documents related to QC Compliance activities.- Guarantee the compliance of activities with regulatory, legal, and internal requirements.- Participate in the preparation of health authority inspections, internal audits, and partner audits, as well as the follow-up of responses to findings.- Perform regulatory and pharmacopeial monitoring impacting QC activities and coordinate necessary actions.- Promote a proactive quality culture, continuous improvement, data integrity, and ethics within the department.Profile- Higher education in biotechnology, pharmacy, chemistry, or an equivalent scientific field.- Minimum 5 years of experience in a GMP biotechnological, pharmaceutical, or chemical environment, including experience in Quality Control.- Good command of quality systems: CAPA, change control.- Experience in the qualification of analytical software and equipment.- Solid troubleshooting and root cause analysis skills in a cGMP environment.- Ability to work in a dynamic and highly regulated environment.- Rigorous, proactive, and team-oriented mindset.- Fluent French and English are essential. jidceabba8aen jit0624aen jpiy26aen