Job Overview
We are seeking a highly skilled Qualified Person (QP) to join our client and support leading pharmaceutical companies in Ireland. The ideal candidate will play a crucial role in ensuring compliance with EU GMP regulations, overseeing quality assurance processes, and safeguarding the release of high-quality pharmaceutical products.
This is a dynamic opportunity for an experienced professional looking to contribute to impactful projects in a thriving pharma sector.
Key Responsibilities
Batch Release & Compliance
- Perform batch certification and ensure products meet EU regulatory requirements.
- Oversee the final release of medicinal products for distribution.
Quality Assurance & GMP
- Maintain compliance with EU GMP standards and other applicable regulations.
- Support internal and external GMP audits and inspections (e.g., HPRA, EMA).
- Investigate and resolve deviations, non-conformances, and CAPAs to ensure product quality.
- Assist in the review and approval of change controls.
Risk Management & Process Improvements
- Lead risk assessments and develop strategies for process optimization.
- Support validation and qualification activities as required.
Documentation & Oversight
- Approve and review critical documentation, including batch records, SOPs, and validation protocols.
- Act as a key point of contact for regulatory bodies and facilitate timely inspections.
Key Requirements
- Must hold EU Qualified Person (QP) certification as defined under EU Directive 2001/83/EC.
- Proven experience in batch release and compliance within a GMP-regulated environment.
- Solid understanding of pharmaceutical manufacturing processes and quality systems.
- Experience in audits (internal and external) and regulatory inspections.
- Knowledge of deviation management, CAPA systems, and change control procedures.
- Exceptional problem-solving and communication skills.
Preferred Qualifications
- Degree in Pharmacy, Chemistry, Microbiology, or related field.
- Experience in release of sterile manufacturing, biologics, or OSD forms.
Why Join?
- Opportunity to work on innovative projects with global pharma leaders.
- Competitive contract rates and flexibility.
- Gain exposure to a diverse range of products and technologies.
Morgan McKinley is acting as an Employment Agency and references to pay rates are indicative.
BY APPLYING FOR THIS ROLE YOU ARE AGREEING TO OUR TERMS OF SERVICE WHICH TOGETHER WITH OUR PRIVACY STATEMENT GOVERN YOUR USE OF MORGAN MCKINLEY SERVICES.
