* 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
Maybe not for you, but for someone else?
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