Key Responsibilities
- Provide quality oversight for the introduction of new products and materials, including coordination with external partners and suppliers.
- Support QA activities across Analytical, Warehouse, and Facilities functions, including deviations, root cause analysis, CAPAs, and change controls.
- Act as a QA representative on cross-functional teams for new product and material introduction.
- Review and approve key documentation such as material packs, QC test specifications, BOMs, and supplier qualification records.
- Develop and monitor supplier performance metrics; participate in material review boards and supplier review meetings.
- Maintain the Approved Supplier List within the supplier management system, ensuring accurate setup and compliance.
- Lead or support deviation investigations, atypical events, and CAPA implementation and closure.
- Author, review, and approve protocols and reports for technology transfer, method qualification, and validation.
- Provide QA oversight for engineering, validation, automation, and utilities commissioning/qualification activities.
- Act as a key quality point of contact at site level and with external stakeholders.
- Drive compliance with regulatory and internal standards; identify gaps and lead continuous improvement initiatives.
- Participate in site quality and plant committees, collaborating with cross-functional teams.
Experience, Knowledge & Skills
- 3-5 years' experience in a QA role within pharmaceutical manufacturing (or similar regulated industry).
- Strong knowledge of regulatory requirements (EU, Irish, and international standards).
- Familiarity with cGMP and GDP guidelines.
- Experience in deviation management, CAPA, and change control systems.
- Background in equipment/process validation and (ideally) sterile manufacturing.
- Strong technical writing and documentation skills.
- Proficiency in Microsoft Office and quality systems.
- Knowledge of Lean Six Sigma principles (desirable).
- Strong teamwork, communication, and stakeholder management skills.
- Ability to work independently, take ownership, and drive tasks to completion.
- Solid problem-solving and decision-making capability.
Qualifications
- Bachelor's degree (or higher) in a science-related field (e.g., Chemistry, Biology, Pharmaceutical Sciences).
