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Quality Assurance Consultant
Ividata Life Sciences. Lead the investigation, management, and closure of deviations, change controls, and CAPA plans .
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 industry, with a strong focus on deviation management, change control, and CAPA processes. Proficient in conducting root cause analyses and preparing for regulatory inspections while ensuring continuous improvement of quality documentation.
Highest-signal resume keywords
Quality Assurance ExperienceProficiency in QMS ToolsRegulatory Standards KnowledgeRoot Cause AnalysisQuality Agreement Review
ATS Keywords
Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills
Deviation ManagementChange ControlCAPARoot Cause AnalysisProduct Quality ReviewsQuality Document ManagementKPI MonitoringRegulatory Compliance
Soft Skills
Analytical SkillsInterpersonal SkillsMethodological RigorSummarization SkillsResponsiveness
Tools & Technologies
TrackWiseVeevaDMS/QMS Systems
Certifications & Qualifications
Degree in Quality EngineeringMaster’s Degree in Pharmaceutical Quality ManagementDoctor of Pharmacy Degree
Industry Keywords
GMPGDPFrench Public Health CodeQuality Management SystemPharmaceutical Industry
About the role
Key responsibilities & impact- Lead the investigation, management, and closure of deviations, change controls, and CAPA plans
- Conduct root cause analyses using the 5 Whys and Ishikawa methods
- Document the associated action plans
- Monitor KPIs related to deviations
- Contribute to the update and continuous improvement of the quality document management system
- Contribute to drafting and formalizing the quality manual for the operating pharmaceutical establishment
- Strengthen the monitoring and oversight of outsourced activities
- Review, verify, and update Quality Agreements with partners, manufacturers, and contract manufacturers
- Analyze, investigate, and approve Product Quality Reviews (PQRs)
- Prepare and support the monitoring of action plans following ANSM inspections
- Join a pharmaceutical company’s operating establishment and contribute to strengthening its Quality Management System
Requirements
What you’ll need- Degree in Quality Engineering, a Master’s degree in Pharmaceutical Quality Management, or a Doctor of Pharmacy degree
- 3 to 5 years of successful Quality Assurance experience within an operating pharmaceutical establishment
- Proficiency in QMS tools, including deviation management, change control, and CAPA
- Proficiency with DMS/QMS systems such as TrackWise, Veeva, or equivalent platforms
- Strong knowledge of regulatory standards applicable to pharmaceutical operators, including GMP, GDP, and the French Public Health Code
- Experience reviewing Quality Agreements and industrial Product Quality Reviews (PQRs)
- Methodological rigor, strong analytical and summarization skills, and excellent interpersonal skills
- Responsive and able to meet regulatory deadlines
Benefits
Comp & perks- Stimulating and collaborative work environment
- High-impact assignments
- Remote work opportunities within a hybrid role
- Assignments with pharmaceutical companies, biotech firms, medical device companies, animal health, cosmetics, and nutrition organizations
- Career growth alongside passionate experts in a constantly evolving environment