Quality Lead | Pharmaceutical Development
Dublin | onsite
An exciting senior Quality opportunity supporting pharmaceutical products across development, NPI, scale-up and commercialisation. You'll work across Quality, Analytical, Manufacturing and CMC, with exposure to OSD, API, external CMOs and pharmaceutical manufacturing.
Key Responsibilities
- Provide QA oversight of analytical qualification, method validation, stability and data integrity.
- Own the Cleaning Validation and Cleaning Verification programme.
- Provide hands-on QA support for GMP manufacturing and on-floor activities across product development and manufacturing programmes.
- Support batch disposition, batch record review and QP disposition.
- Review deviations, CAPAs, change controls, SOPs and risk assessments.
- Partner with Analytical Development, Manufacturing and Regulatory/CMC teams.
- Support GMP audits, inspections and regulatory activities.
Experience Required
- BSc in a scientific discipline or equivalent.
- 10+ years' pharmaceutical industry experience.
- Strong QA, analytical, manufacturing and cleaning validation experience.
- OSD experience highly desirable.
- Strong knowledge of FDA/EU cGMP, data integrity and validation lifecycle principles.
- Experience with Veeva, TrackWise Digital, ValGenesis and/or SAP advantageous.
- Strong stakeholder management and problem-solving skills.
