Senior QA Expert

• Act as QA single point of contact for assigned manufacturing activities

• Author, review, and approve SOPs, risk assessments, and quality documents

• Manage and approve deviations, CAPAs, change controls, and validation records

• Provide QA oversight to ensure GMP compliance in manufacturing

• Support investigations (root cause analysis, impact assessment, action plans)

• Participate in audits and inspections (internal & external)

• Contribute to quality system improvements and lean initiatives

• Collaborate with cross-functional teams and external partners

• Define and monitor Quality KPIs and project progress

• Support onboarding and guide team members when needed

• Master’s or Ph.D. in Chemistry, Biology, Pharmacy, or related field

• 5–10 years’ experience in QA/QC within pharmaceutical manufacturing

• Strong knowledge of cGMP and regulatory compliance

• Experience with deviations, CAPAs, change controls, and validation

• Familiarity with TrackWise and/or KNEAT

• Excellent problem-solving, decision-making, and planning skills

• Strong collaboration skills and customer-oriented mindset