Job Description
Position: 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 full alignment with EU GMP Annex 16, EU Directives 2001/83/EC and 2001/20/EC, as well as HPRA guidelines.
* Deviation & CAPA Oversight: Investigate manufacturing deviations, non-conformances, and changes. Conduct root cause analysis and implement corrective and preventive actions (CAPAs).
* GMP Advisory & Coordination: Serve as 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: Create, refine, and optimise 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 all steps comply with latest regulatory standards and internal policies.
* Regulatory Inspection Support: Act as key representative during regulatory inspections, including HPRA audits.
* Regulatory & Industry Insight: Stay up-to-date on evolving industry trends and regulatory updates.
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.
* Regulatory Expertise: In-depth knowledge of EU and Irish GMP regulations.
* Professional Experience: At least 5 years' experience working in a GMP-regulated pharmaceutical manufacturing environment.
* Making a meaningful impact on the quality and compliance of products for cancer care.