Job Title: Tenured Qualified Person (QP)
Location: Dublin, Ireland Industry: Pharmaceutical Manufacturing
Key Responsibilities:
* Batch Certification & Product Release: Ensure timely certification and release of pharmaceutical batches in alignment with EU GMP Annex 16, EU Directives 2001/83/EC and 2001/20/EC, as well as HPRA guidelines.
* Deviation & CAPA Oversight: Lead investigations into manufacturing deviations, non-conformances, and changes. Conduct root cause analysis and implement corrective and preventive actions (CAPAs).
* GMP Advisory & Coordination: Serve as a go-to expert for GMP-related matters, collaborating with Production, Engineering, QC, and Technical Affairs to resolve regulatory issues and ensure compliance standards.
* Quality System Development & Optimisation: Play a pivotal role in creating, refining, and optimising quality systems across the site.
* Documentation Oversight: Review, approve, and ensure compliance of key quality documents such as SOPs, batch records, and validation protocols.
* Regulatory Compliance Assurance: Oversee product release process to ensure compliance with regulatory standards and internal policies. Participate in internal audits and oversee supplier qualification processes.
* Regulatory Inspection Support: Act as a key representative during regulatory inspections, including HPRA audits, ensuring successful outcomes by preparing for audits and facilitating positive communication with inspectors.
* Regulatory & Industry Insight: Stay up-to-date on evolving industry trends and regulatory updates. Provide guidance on integrating these changes into company practices to ensure ongoing regulatory compliance.
Qualifications & Skills:
* Degree: 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 with at least 4 years of experience 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 batch release and certification process.
* Manufacturing & Quality Systems Knowledge: Strong familiarity with pharmaceutical manufacturing processes, quality management systems, and validation requirements.
* 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 make a meaningful impact on the quality and compliance of products for cancer care.