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Support quality remediation initiatives through CAPA management and GMP compliance activities. Perform technical writing, document review, and risk assessment activities in a regulated environment. Collaborate with cross-functional teams to ensure timely completion of quality deliverables.
Job Responsibility
Develop, manage, and execute CAPA records aligned with regulatory and internal quality standards
Perform technical writing and detailed review of investigations, protocols, and reports
Ensure GMP compliance across quality and documentation deliverables
Identify compliance gaps, risks, and improvement opportunities
Collaborate with SMEs and cross-functional teams to support timely CAPA closure
Contribute to risk assessments and risk management activities using a science-based approach
Support inspection-ready documentation and quality processes
Maintain project timelines and deliverables
Requirements
Experience in GMP-regulated environments preferred
Strong experience with CAPA processes and quality remediation activities
Experience in technical writing and document review within regulated industries
Familiarity with risk assessment and risk management practices preferred
ICH Q9 experience is an advantage
CAPA management
GMP compliance
Technical writing and document review
Investigation and report review
Risk assessment and risk management
Cross-functional collaboration
Problem-solving and analytical skills
Time management and organization
Bachelor’s degree in Life Sciences, Pharmacy, Engineering, Quality, or related field preferred
Experience in pharmaceutical, biotech, or regulated manufacturing environments preferred
Ability to work independently and manage multiple deliverables
Nice to have
Experience in GMP-regulated environments preferred
Familiarity with risk assessment and risk management practices preferred