- Manage and maintain the Quality System for the Cluster
- Ensure compliance of promotional activities to applicable standards (e.g. LEEM Charte, HAS reference standards,...)
- Definition, implementation, monitoring of audits plan and monitoring of subcontractors involved in pharmaceutical activities
- Ensure readiness for Inspections by competent authorities or audits
- Ensure deviations, change controls, risk assessments, CAPAs, recalls and product returns, batch tracking are processed and tracked accordingly
- Review packaging materials, promotional and non-promotional materials
- Coordinate initial and continuous training for employees, including tracking, monitoring of knowledge acquisition and archiving
- Serve as a backup for additional responsibilities the Pharmaceutical Affairs department.
- In addition, the Pharmaceutical Affairs Manager will act as Deputy Responsible Pharmacist, to cover periods when the Responsible Person is unavailab
According to article R and R of the French Public Health Code, the Responsible Pharmacist position covers a broad area of responsibilities as Regulatory (Marketing Authorization and labelling), Quality (Complaints, Batch traceability and batch recalls, Manufacturing/Distribution/Storage/Transport of medicinal products), Import/Export activities, Pharmacovigilance, Advertising, Medical information related to the "Exploitant" status and participation in Research & Development activities. - 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 <20 % #LI-CK1 #LI-Onsite Full Time employees across the globe enjoy a range of benefits, including, but not limited to: · Generous vacation time and public holidays observed by the company · Volunteer days · Long term incentive and Employee stock purchase plans or equivalent offerings · Employee wellbeing benefits · Fitness reimbursement · Tuition sponsoring · Professional development plans * Benefits vary by region and country
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Pharmaceutical Affairs Manager/ Deputy Responsible Pharmacist, France - Paris, France - Ultragenyx Pharmaceutical
Description
Position Summary:
ultra focused – Work together to fearlessly uncover new possibilities
Working directly with the Responsible Pharmacist & Director of Pharmaceutical Affairs France & Benelux, the Pharmaceutical Affairs Manager / Deputy Responsible Pharmacist, will manage the quality system and ensures compliance with applicable pharmaceutical regulations for the French & Benelux cluster. This position will require close collaboration with the European Qualified Person and Global QA.
Work Model:
Core Lab & Ops: This role typically requires that the majority of the work be conducted on-site and thus will be subject to certain on-site safety protocols during the pandemic.
Responsibilities:
Requirements:
