QUALIFICATIONS & VALIDATIONS OFFICER (M/F)
Centre Lab, a human-sized pharmaceutical laboratory (SME of 47 employees), located in the heart of Creuse in Guéret (23), is currently undergoing a major expansion phase. It is within this stimulating context of strong growth that we are recruiting our future Qualifications & Validations Officer. Contribute to our health mission while working in an environment that values autonomy, rigor, and well-being.
Reporting directly to the Qualification Validation Manager, you will carry out equipment qualification activities and process and cleaning validation, in accordance with current procedures. You will contribute to ensuring the compliance of equipment and processes in order to ensure product quality and compliance with regulatory requirements (BPF, GMP, ISO).
Your Main Missions: Equipment Qualifications -> Perform equipment qualifications (production, utilities, laboratory) according to the site schedule. Write and execute qualification protocols (IQ/OQ/PQ) as well as associated reports.
Process & Cleaning Validations -> Participate in process validations (trials, field monitoring, documentation). Perform cleaning validations (sampling, monitoring of results, reports).
Metrology & Fieldwork -> Ensure operational execution in the field and perform metrological verifications according to the defined schedule.
Quality Management & Deviations -> Participate in the processing of deviations, anomalies, and associated investigations under supervision. Apply and update the quality documentation for the scope (protocols, reports, procedures).
Cross-functional Collaborations -> Exchange fluidly and reactively with internal departments (Production, Quality Assurance, R&D, Quality Control, Maintenance) and with external interlocutors (suppliers, service providers).
Training / Diploma: Bac+5 (Engineer, Master 2 Scientific or Pharmacist) with a specialization in industrial processes, quality management, or qualifications/validations. Knowledge & Technical Expertise: Mastery of BPF and the Pharmacopoeia. Knowledge of ISO 13485 and ISO 22716 standards. Mastery of risk analysis and quality tools/methods (5M, AMDEC, ICH). Operational English in both writing and speaking. Soft Skills: Excellent analytical and writing skills, sense of practical organization, rigor, and ability to propose solutions. Team spirit, interpersonal ease, and ability to adapt communication according to interlocutors.
What we offer you (Working conditions): Contract: Full-time CDI 35 hours Company hours: Monday to Thursday from 08:30 to 16:30 and Fridays from 08:30 to 15:30 Remuneration based on the RMMG scale of the collective agreement, according to the classification of the selected profile. Mutual insurance, Provident fund, Meal vouchers.
National collective agreement for the manufacture and trade of pharmaceutical, parapharmaceutical, and veterinary products.