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Manager of Pharmaceutical Affairs and Compliance
Il y a 2 mois
Manager of Pharmaceutical Affairs / Deputy Responsible Pharmacist
In collaboration with the Responsible Pharmacist and the Director of Pharmaceutical Affairs for France and Benelux, the Manager of Pharmaceutical Affairs / Deputy Responsible Pharmacist will oversee the quality management system and ensure adherence to relevant pharmaceutical regulations within the French and Benelux regions. This role necessitates close interaction with the European Qualified Person and Global Quality Assurance teams.
Key Responsibilities:
- Oversee and uphold the Quality Management System
- Ensure promotional activities align with regulatory standards
- Develop and implement audit plans, supervising subcontractors engaged in pharmaceutical operations
- Prepare for inspections and audits
- Manage deviations, change controls, risk assessments, CAPAs, recalls, and product returns
- Evaluate packaging materials and promotional materials
- Coordinate training initiatives for staff
- Act as a backup within the Pharmaceutical Affairs department
Qualifications:
- Pharmacist degree, fluent in both French and English
- Certification as Deputy Responsible Pharmacist with a minimum of 2 years in that capacity
- 5-10 years of experience in Quality Assurance
- 6-12 months of experience in Pharmacovigilance
- Familiarity with GxP guidelines and French and European regulations
- Willingness to travel less than 20%
Company Benefits:
- Generous vacation and public holiday allowances
- Long-term incentive and stock purchase programs
- Employee wellness initiatives
- Fitness reimbursement options
- Tuition assistance programs
- Professional development opportunities
