Director Quality, Head Pharmacist

Director Quality, Head Pharmacist

Catalent

Beinheim, France

Position Summary

The Director Quality, Head Pharmacist is responsible for setting the strategic direction, properly staffing and maintaining the Quality Management Systems (QMS) to assure the site is always complaint. They are responsible for establishing and maintaining the site metrics, management review, and building a Patient First culture at the site. The Director of Quality at the site is the most responsible person for batch disposition. The Director of Quality is responsible to provide project guidance and support and work with customers to resolve quality concerns as appropriate.

As Head pharmacist you will be responsible to ensure legal pharmaceutical responsibility for the site.

The Role

  • Direct a team of Quality professionals. Provide development and disciplinary actions as needed to assure the department remains engaged and motivated.
  • Manage and drive relations with French and international authorities & ensure compliance with the CSP (French Health Code), GMP (Good Manufacturing Practices)
  • Responsible for the management of manufacturing licenses, GMP certificates, SMF (Site Masterfile) and import and export licenses
  • Organise and monitor all the company's pharmaceutical operations, including research and development, manufacturing, control, release, pharmacovigilance, batch tracking and withdrawal, distribution, import and export of medicines and corresponding storage operations;
  • As a Qualified Person/QP, ensure responsibility for the compliance of productions upon departure from the site or even the release of lots according to agreements with customers
  • Report to other company or organisation leaders any obstacles or limitations to the exercise of these responsibilities.
  • Informing the General Manager of the competent authority in case of disagreement on the application of the rules adopted in the interest of public health is opposed to a management, administration, management or control body
  • Participates in the deliberations of the governing, administrative, management or supervisory bodies, or those of any other body with an executive office, the company or the organisation, when these deliberations relate to the performance of the tasks under its responsibility or may affect them.

The Candidate

  • License to practice as a head pharmacist/Qualifies Person with at least 3-4 years in a similar position working for a pharmaceutical company’s quality function.
  • Ability to bring projects to a timely completion using Catalent systems
  • Good working knowledge of the subject area
  • Knowledge of cGMP, GLP, ICH, and EP, USP, BP regulations or guidelines
  • Expert knowledge as head pharmacist and qualified person according to French Health Code art. R.5124-36.
  • Languages: French (main preference native speaker) & English, business fluent

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© EuroJobsites 2020

EuroJobsites is a registered company number: 4694396 VAT number: GB 880 9055 04

Registered address: EuroJobsites Ltd, Unit 8, Kingsmill Business Park, Kingston Upon Thames, London, KT1 3GZ, United Kingdom

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