Associate Quality Assurance Manager

Associate Quality Assurance Manager

Mundipharma

Paris, France

The Associate Quality Assurance Manager must hold a Pharmacy Degree (must be eligible for registration with the French Order of Pharmacists) and will look to be trained in a Deputy Pharmacist role.

Role and Responsibilities

• Ensuring that all the activities performed are maintained in compliance with applicable regulations, that appropriate authorizations/licenses and certificates are in place and current and that the integrity and safety of product are maintained throughout distribution via an effective Quality Management System.
• Regional legislation change review. Responsible for implementing relevant changes on a local level when regional/global legislation changes.
• Quality metrics reporting in accordance with the global reporting system of the company.
• Reporting and escalation of urgent quality issues to the FR-BeNeLux Quality Pocket Lead and the Responsible Pharmacist.
• Responsible for conducting Quality impact assessment on global/central changes affecting the company (MAH) and ensuring creation and completion of necessary action items. Responsible for ensuring risk assessment principles are applied.
• Ensure an effective Quality Management System being established/implemented, maintained and operated in line with current GxP requirements, local regulatory standards, and Mundipharma standards for all relevant product classes on the global electronic platforms used in the company.
• Maintenance and operation of local GxP change controls, deviations and CAPAs on the global electronic platforms used in the company.
• Appropriate receiving and handling of complaints, (suspected) product defects and (suspected) falsified medicinal products, security incidents, product recalls, adverse drug reactions and other safety information, and reporting to the Responsible Pharmacist.
• Periodic evaluation of the effectiveness of the arrangements in place for product recalls.
• Monitoring of quality system (including trending) and continuous improvement via Product Quality Reviews (PQRs), audits and self-inspections, Quality metrics and Quality Management Reviews.
• Ensuring the necessary qualifications and technical agreements/delegation letters etc. are in place for 3rd party GxP services provided and products supplied to the local company.
• Ensure recommended product shortage prevention and management plans in place.

What you’ll bring

• University degree in Pharmacy (must be eligible for registration with the French Order of Pharmacists).
• Master's Degree in Quality Assurance or Regulatory Affairs or other Pharmaceutical Affairs would be Ideal.
• Ability to work collaboratively maintaining good working relationships with cross functional teams and partners actively participating contributing to team success.
• Fluent in spoken and written English. Other languages appreciated (Dutch).
• Proficient in the use of Microsoft Office applications.
• Competent in use of databases (preferred).
• Proactive, pragmatic, independent, organized and self-confident.
• Customer focused and cross-functional thinking and behavior.

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