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Curia Quality Control Manager - Tonneins France in Bon-Encontre, France

Curia provides global contract research and manufacturing services to the pharmaceutical and biotechnology industries.

Join our talented workforce, where a commitment to excellence and a customer focused attitude is everything. We pursue excellence because our work has the power to improve patients’ lives with the pharmaceuticals we develop and manufacture.

In this role you will:

  • Coordinate the Quality Control activities of the Tonneins site, according to the rules and standards of safety and quality in force in the company.

  • Organize, manage and coordinate the operations necessary for the operation of the Quality Control laboratories in compliance with GMP rules, current standards (ISO 9001, 14001, OHSAS 18001), laboratory-specific procedures and safety rules.

  • Be the guarantor of the analytical quality of active pharmaceutical ingredients and intermediates.

  • Be the guarantor of compliance with Good Laboratory Practices within the company.

  • Collaborate with all departments of the company.

Responsibilities:

  • Rule on the quality of raw materials, intermediates and finished products from the Tonneins site and release them (for use in manufacturing or shipment to customers) within the limits of defined responsibilities (see Q/F/004)

  • Sign finished product analysis certificates

  • Organization of sampling and prioritization of the control of batches of materials in line with the production/release schedule

  • Check the proper execution of the prescribed analyzes in compliance with procedures, control plans, safety rules and deadlines

  • Implement quality processes, through the management of out-of-specification results, deviations, CAPAs, and Change Controls

  • Conduct, at the laboratory level, investigations relating to out-of-specification and out-of-trend results

  • Write the procedures, technical instructions and analysis methods of Tonneins's Quality Control laboratory

  • Ensure that laboratory measuring instruments are qualified and calibrated in accordance with defined procedures and specifications

  • Ensure that laboratory technicians are trained and qualified in analysis techniques and methods

  • Prepare and participate in customer and institutional audits (ANSM, FDA)

  • Monitoring and updating service activity and performance indicators

  • Carry out the regulatory watch relating to the activity of the Quality Control laboratory

  • Define a roadmap and a continuous improvement policy in accordance with the company's objectives

  • Establish the annual budget of the Quality Control laboratories in accordance with the objectives of the Management and ensure its follow-up

Must haves:

  • Ability to speak both English and French

  • GMP and GLP experience

  • Education in a related life sciences field

  • 4+ years of relevant work experience in Pharma or Biotech

  • HPLC and GC experience

  • Analytical chemistry experience

  • Knowledge of the risks associated with handling the products

  • The ability to carry out tasks in compliance with Quality, EHS and OEA procedures

Preferred:

  • Auditing experience

  • Stability experience

  • Microbiology

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