Description

Job description:
• 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

Requirements:
• 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