In this context, we are recruiting a Commercial Quality Assurance Pharmacist for a 7 to 10 month contract.
Responsibilities:
1.Pharmaceutical Operations Management:
· Organize and oversee daily pharmaceutical operations.
· Ensure the compliance of marketed products with current regulations.
2. Product Quality and Safety:
· Participate in defining and implementing quality policies.
· Ensure the proper functioning of the quality management system.
· Manage customer complaints and product returns.
· Report necessary quality defects or disruptions to the authorities.
3. Training and Supervision:
· Train staff in good pharmaceutical
practices.
· Supervise operations delegated to Quality Assurance Managers.
4. Coordination with Authorities and Partners:
· Maintain liaison with health authorities and professional bodies.
· Sign agreements with subcontractors and partners.
5. Documentation and Compliance:
· Ensure the compliance of labeling and promotional materials.
· Compile data and organize periodic evaluations of the quality system.
· Participate in internal and external audits and ensure preparation and follow-up of inspections.
6. Change and Deviation Management:
· Manage changes and deviations with various levels of investigation to identify risks, root causes, and associated CAPAs.
· Ensure that initial and ongoing training programs are implemented and kept up to date.
Required qualifications and work experience:
Required Skills:·
Regulation 2001/83 relating to medicinal products
· Good Distribution Practices for medicinal products
· Public Health Code· European and French Good Pharmacovigilance Practices
. ISO 22716/13485· Food Supplements regulations
Professional Qualifications:·
Pharmacy degree·
2/3Y Experience·
Eligible for registration as Interim Responsible Pharmacist
Required competencies :
. Rigorous and organized
· Good communication skills
· Analytical thinker
· Business Oriented
· Agility to navigate across complexity- technical and matrix organization