Operational Quality Assurance Manager (M/F)
About the company
Centre Lab, a pharmaceutical laboratory based in Creuse in the city of Guéret (23), specializes in the development, manufacturing, packaging, and distribution of health products: medicines (hospital preparations, specialties with AMM or experimental medicines) and medical devices.
Your tasks
Reporting to the Pharmaceutical Management and in direct link with all departments (Production, Quality Control, QA System, Qualifications/Validations, Maintenance, etc.), you guarantee the field application of current rules and standards (GMP, Pharmacopoeia, ISO standards) to enable the secure market release of products.
Your main missions -Documentary control: Ensure the documentary review of batch records, guarantee the compliance of production and control processes,
-Operational quality management: Lead investigations following non-conformities, deviations, OOS/OOT results, and manage customer/supplier complaints.
-Continuous improvement and Change Control: Manage Change Control, propose and supervise the follow-up of CAPA resulting from audits and inspections.
-Audits and Quality Reviews: Perform or coordinate PQR, actively participate in internal audits, supplier/subcontractor audits, and regulatory inspections.
-Field support and training: Support operational teams in the application of GMP and lead quality training (initial and continuous).
Requirements
For this key position, the following elements are minimum requirements ->
In-depth mastery of Good Manufacturing Practices (GMP), the Pharmacopoeia, and applicable frameworks. Perfect mastery of quality documentation, CAPA management, Change Controls, and investigations. Knowledge of applicable standards and analysis tools (5M methods, FMEA, ICH). A good command of professional English (oral and written) is indispensable. Knowledge of medical devices constitutes a major asset.
Rigor and precision: Guarantor of regulatory compliance and the safety of the production chain. Reactivity and priority management: Ability to quickly analyze anomaly or deviation situations and respond effectively. Communication skills and pedagogy: Ability to transmit quality requirements, to dialogue with field operators, and to adapt your discourse to different interlocutors. Analytical spirit and proactive approach: Willingness to continuously improve the site's processes and practices.
Master's degree (Bac+5) in science or technology, with solid experience in operational quality assurance. This position does not require the title of Pharmacist.
What we offer
Remuneration and Benefits
- €36,000 gross/year to €48,000 gross/year depending on experience and profile
- Health insurance, Provident fund, Meal vouchers
How to apply
Application Process CV and cover letter to be sent to rh@centre-lab.com 1st brief HR interview by phone. 2nd technical interview via video call with the department manager (reference check with candidate's consent). 3rd interview on-site with HR and department manager.
Other
Please note: This position is resolutely oriented towards operational support, real-time problem solving, and driving quality on the production floor (and is not a sedentary office position).
Contract type: CDI Start date: As soon as possible Working time: Full time Status: Executive (cadre), day-rate scheme
National collective agreement for the manufacture and trade of pharmaceutical, parapharmaceutical, and veterinary products. </body>