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Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates expertise in Quality Management Systems (QMS) and regulatory compliance within the pharmaceutical sector, with a strong focus on GxP guidelines and risk management. Capable of managing product quality, supplier qualifications, and regulatory intelligence while fostering relationships with stakeholders and authorities.
Highest-signal resume keywords
Quality Management System (QMS)GMP/GDP&GVP GuidelinesPharmacien ResponsableRegulatory IntelligenceGxP Knowledge
ATS Keywords
Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills
Deviations ManagementCAPA ManagementChange Control ManagementProduct Technical Complaints (PTC) ManagementSelf-InspectionsInternal AuditsExternal AuditsMarketing Authorization Lifecycle ManagementProduct Quality ReviewsMITM Analysis
Soft Skills
High Sense of ResponsibilityExcellent Management SkillsOrganizational SkillsDecision-Making AbilityIndependence
Certifications & Qualifications
Graduated PharmacistRegistered/Registrable at the College of Pharmacists Section B
Industry Keywords
Pharmaceuticals ExploitantPublic Health CodeQuality Risk ManagementSupplier QualificationProduct RecallsCounterfeit Product ManagementGxP ComplianceFrench Health Code Compliance
About the role
Key responsibilities & impact- Support the Exploitant Quality Assurance function
- Implement, maintain, and improve the Quality Management System (QMS) in line with Group Quality Policies, GMP/GDP&GVP guidelines, and the Public Health Code
- Participate in training programs for affiliate personnel
- Contribute to continuous improvement through risk analysis
- Manage deviations, CAPAs, and change controls
- Manage Product Technical Complaints (PTC)
- Participate in self-inspections and internal and external audits
- Manage supplier qualification and monitoring
- Assist the Pharmacien Responsable with product recalls and potential counterfeit product cases
- Approve returns to saleable stock when necessary
- Participate in inspection readiness, Management Review, and Quality Risk Management
- Review Product Quality Reviews
- Manage the marketing authorization lifecycle of marketed products
- Review product packaging materials intended for the territory
- Perform Regulatory Intelligence
- Assist with out-of-stock situations
- Set up MITM analysis and PGP, if applicable
- Monitor shortage situations
- Assume pharmaceutical responsibility during the planned or unplanned absence of the Pharmacien Responsable
- Promote the Exploitant regulatory approach with internal and external stakeholders and control its implementation
- Develop trusting professional relationships with governmental authorities
Requirements
What you’ll need- Graduated Pharmacist
- At least 3 years of experience in a Pharmaceuticals Exploitant
- Experience compliant to article R.5124-16, R.5121-164 of French health code
- Registered/registrable at the College of Pharmacists section B as Pharmacien Responsable Intérimaire Exploitant
- Ideally a master degree in regulatory/quality affairs
- Fluent in English, both written and spoken
- Solid knowledge of GxP and Exploitant regulation
- High sense of responsibility
- Excellent management and organizational skills
- Ability to make decisions including in stressful situation
- Sense of priority and deadlines
- Perfect understanding of potential public health issues related to activity
- Ability to demonstrate independence, objectivity, ethics and confidentiality
Benefits
Comp & perks- Private Health Insurance
- Pension Plan
- Paid Time Off (25 + 11 days)
- Work From Home
- Training & Development
- Performance Bonus
- Meal Vouchers