Pharmaceutical Quality Assurance Manager (M/F)

Job Description:

Company:

Le CabRH, a recruitment and direct approach firm, is recruiting for its client, a pharmaceutical industrial site, a Pharmacien Responsable (M/F)

Job Details:

Reporting to the Site Director and as a member of the Management Committee, your mission will be to define and coordinate the implementation of the Quality Assurance & Quality Control policy. You will be responsible for the continuous update and improvement of the site's quality management system. You will manage the QA team and the QC team.

Your objectives will be as follows:

• Define the process validation policy and ensure its deployment across the site
• Define and monitor KPIs within your scope of activity
• Contribute to the validation - qualification strategy
• Organize and maintain the quality management system
• Ensure and certify that medicines are manufactured in accordance with BPF / GMP requirements, MA dossier requirements, and the specifications and terms of reference established with each client
• Monitor internal and external audit plans and quality assurance contracts with various external partners
• Supervise quality documentation
• Analyze and diagnose: root cause analysis (deviations, OOS, CC CAPA), analysis of the evolution of quality systems and tools and definition of their implementation, handling of major malfunctions, monitoring of quality indicators, and leading quality reviews
• Evaluate the criticality of major malfunctions and propose relevant solutions
• Conduct French and international regulatory monitoring
• Manage customer complaints
• Manage the human resources of the Quality Assurance team (recruit, evaluate, train, retain, motivate)
• Foster a good social climate within your team
• Represent the site with administrative authorities and answer questions regarding quality audits and inspections
• Manage batch release after verifying the compliance of finished products
• Anticipate and manage quality assurance risks and needs in the short, medium, and long term within the framework of introducing new projects

Profile sought:

You hold a degree as an Industrial Pharmacist eligible for registration as a site delegated pharmacist and have successful initial experience in a Quality Assurance position with a managerial dimension. Knowledge of the BPF / GMP environment. Good level of English

Additional Information: €120k gross annual Your application, as well as the search, are confidential.