Position: Tenured Qualified Person (QP)
Location: Dublin, Ireland
Industry: Pharmaceutical Manufacturing
Key Responsibilities:
- Batch Certification & Product Release: Ensure the timely certification and release of pharmaceutical batches in full alignment with EU GMP Annex 16, EU Directives 2001/83/EC and 2001/20/EC, as well as HPRA guidelines
- Deviation & CAPA Oversight: Take the lead in investigating manufacturing deviations, non-conformances, and changes. Ensure root cause analysis is conducted and that appropriate corrective and preventive actions (CAPAs) are effectively implemented.
- GMP Advisory & Coordination: Serve as the go-to expert for GMP-related matters, collaborating with Production, Engineering, QC, and Technical Affairs to resolve regulatory issues and ensure adherence to compliance standards.
- Quality System Development & Optimisation: Play a pivotal role in the creation, refinement, and optimisation of quality systems across the site.
- Documentation Oversight: Review, approve, and ensure compliance of key quality documents such as SOPs, batch records, and validation protocols, guaranteeing their alignment with regulatory and organizational standards.
- Regulatory Compliance Assurance: Oversee the product release process to ensure all steps comply with the latest regulatory standards and internal policies. Participate in internal audits and oversee supplier qualification processes, ensuring adherence to GMP regulations and contractual commitments.
- Regulatory Inspection Support: Act as a key representative during regulatory inspections, including HPRA audits, ensuring successful outcomes by preparing for audits, managing documentation, and facilitating positive communication with inspectors.
- Regulatory & Industry Insight: Stay up-to-date on evolving industry trends and regulatory updates. Provide guidance on the integration of these changes into company practices to ensure ongoing regulatory compliance.
- Collaboration on Quality Initiatives: Engage in key projects and initiatives across departments to streamline processes, improve compliance, and drive operational efficiency, ensuring high-quality standards are met across the board.
Qualifications & Skills:
- A degree in Pharmacy, Chemistry, Biology, or another related scientific discipline.
- QP Certification: Fully certified as a Qualified Person (QP) under EU Directive 2001/83/EC or 2001/20/EC and have spent at least 4 years on a licence.
- Regulatory Expertise: In-depth knowledge of EU and Irish GMP regulations, as well as the broader pharmaceutical regulatory landscape.
- Professional Experience: At least 5 years' experience working in a GMP-regulated pharmaceutical manufacturing environment, with substantial expertise in the batch release and certification process.
- Manufacturing & Quality Systems Knowledge: Strong familiarity with pharmaceutical manufacturing processes, quality management systems, and validation requirements, particularly for oral solid dosage forms.
- Audit & Inspection Expertise: Demonstrated experience in managing and leading regulatory audits, especially with HPRA or similar agencies.
- Familiarity with eQMS: Experience with electronic Quality Management Systems (eQMS) is a plus.
This position represents an exciting opportunity to join a leading pharmaceutical organisation in Dublin and to make a meaningful impact on the quality and compliance of products for cancer care. If you are a seasoned QP with a strong track record in ensuring the highest standards of pharmaceutical quality, we invite you to apply below or reaching out to Kellie on
