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Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates expertise in equipment qualification and validation processes, including writing and executing IQ, OQ, and PQ protocols, while ensuring compliance with pharmaceutical regulatory requirements such as GMP and GDP. Strong analytical skills and attention to detail are essential for preparing risk assessments and qualification reports.
Highest-signal resume keywords
Equipment QualificationValidation ProtocolsPharmaceutical Regulatory RequirementsRisk AssessmentV-Model 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
IQ ProtocolsOQ ProtocolsPQ ProtocolsFAT ProtocolsSAT ProtocolsQualification ReportsValidation ReportsMaster Qualification PlanMaster Validation PlanAnalytical Skills
Soft Skills
Attention To DetailInterpersonal Skills
Industry Keywords
Pharmaceutical IndustryGMPGDP21 CFR Part 11Criticality AnalysesGeographical Mobility
About the role
Key responsibilities & impact- Participate in the design review of systems
- Review suppliers’ FAT protocols and verify their consistency with the functional analysis
- Complete supplier SATs
- Receive and commission equipment (FAT/SAT)
- Participate in preparing risk assessments and criticality analyses
- Prepare the master qualification plan
- Write and execute IQ, OQ, and PQ protocols
- Track non-conformities and associated corrective actions
- Prepare qualification reports
- Assess the need for specific equipment for C&Q testing
- Train testers on the protocols
- Plan and coordinate testers and support department interventions
- Prepare the master validation plan
- Write and execute validation protocols in collaboration with Production
- Prepare validation reports
Requirements
What you’ll need- Master’s degree (Bac+5) in General Engineering, Process Engineering, Production, or Utilities
- At least 5 years of experience with equipment
- Knowledge of the pharmaceutical industry would be highly valued
- Proficiency in pharmaceutical regulatory requirements: GMP, GDP, and 21 CFR Part 11
- Comprehensive knowledge of the V-model is required
- Technical proficiency in English would be an advantage
- Strong analytical skills, attention to detail, and excellent interpersonal skills
- Occasional travel to suppliers in France or internationally
- Geographical mobility within France may be required
Benefits
Comp & perks- Company work-from-home policy
- Works Council benefits (holiday vouchers, cultural benefits, sports activity subsidy, etc.)
- 13 additional leave days (RTT) plus a time savings account
- Meal voucher card
- Health and disability insurance
- Holiday bonus
- Employee referral bonus
- Contribution toward public transportation passes or sustainable mobility allowance