Pharmaceutical Affairs Manager/Deputy Responsible Pharmacist Role in France
il y a 4 semaines
Position Overview:
This role is focused on managing the quality system and ensuring compliance with applicable pharmaceutical regulations for the French & Benelux cluster.
As a Pharmaceutical Affairs Manager/Deputy Responsible Pharmacist, you will work closely with the Responsible Pharmacist & Director of Pharmaceutical Affairs France & Benelux to ensure the quality and compliance of our products.
Key Responsibilities:
- Manage and maintain the Quality System for the Cluster
- Ensure compliance of promotional activities to applicable standards
- Definition, implementation, monitoring of audits plan and monitoring of subcontractors involved in pharmaceutical activities
- Ensure readiness for Inspections by competent authorities or audits
- Process and track deviations, change controls, risk assessments, CAPAs, recalls and product returns, batch tracking
- Review packaging materials, promotional and non-promotional materials
- Coordinate initial and continuous training for employees
- Serve as a backup for additional responsibilities the Pharmaceutical Affairs department
- Act as Deputy Responsible Pharmacist to cover periods when the Responsible Person is unavailable
Requirements:
- Pharmacist diploma, with fluent French and English language skills
- Qualification as Deputy Responsible Pharmacist and at least 2 years' experience in that role
- 5-10 years' experience in Quality Assurance
- 6-12 months experience in Pharmacovigilance and batches follow up
- Knowledge of GxP's, with a high focus on French and European regulations, GMP, GDP and GVP
Travel
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