BACKGROUND
The Group of this company is a European leader in pharmaceutical development and manufacturing (CDMO); It is a French group with 1,300 employees and a turnover of nearly €150 million organized around 6 sites and 5 subsidiaries.
One of the subsidiaries employs 320 people at its site in Eure et Loir and specialises in dry forms and the manufacture of tablets, capsules, sugared almonds and sachets.
The Quality Department of this site needs to be supported by Product Quality Assurance – Batch Release. The site’s Human Resources department asked us for a reinforcement mission.
DEVICE
An experienced interim manager, Pierre JEAN has a full understanding of the scope of the Product QA Pharmacist profession. He has carried out several missions with laboratories, distributors, pharmaceutical depositories, etc. His human qualities, which he has been able to develop through his long experience, were obvious to the new quality director as well as to the pharmacist in charge of Product QA to support him in his mission.
MISSION
The main mission, in direct contact with the Product QA Responsible Pharmacist, is to ensure the compliance of the medicines produced and to ensure the release of batches on the market by delegation of the Responsible Pharmacist, in compliance with the legislation (GMP) and regulations in force.
More specifically, the manager:
- Ensures the review of batch files and their release by delegation of the Pharmacist in Charge
- Takes charge of the anomaly process (investigation and proposals for corrective actions in collaboration with supervisors), decision-making following a non-compliance
- Tracks and validates incident records
- Follows up and processes complaints, investigates and implements actions if necessary
- Monitors and updates service quality indicators
- Tracks CAPA incidents and customer complaints
- Participates in the process and in continuous improvement projects (management or participation)
- Coordinates file review schedules (tool/review)
- Audits batch records on the shop floor
- Ensures the management of the department in the absence of the Product Quality Manager