QP

Walker Cole International is supporting an Ireland-based life sciences organisation specialising in the manufacture of sterile medicinal products in the appointment of a Qualified Person (QP). This role will provide oversight of batch certification and ensure full compliance with EU GMP requirements while supporting ongoing manufacturing and operational activities within a highly regulated sterile production environment.

This position will play a critical role in maintaining and strengthening the organisation’s Pharmaceutical Quality System (PQS), ensuring compliance with global regulatory standards, and acting as a key quality representative for regulatory authorities. The successful candidate will provide hands-on QP support across sterile manufacturing, quality systems, and cross-functional teams.

Key Responsibilities

• Act as a Qualified Person (QP) named on the Manufacturer’s Authorisation, certifying batches in accordance with EU GMP and Directive 2001/83/EC
• Ensure all products are manufactured, tested and released in compliance with EU GMP and global regulatory requirements
• Maintain oversight of sterile and aseptic manufacturing operations
• Ensure the organisation maintains a continuous state of inspection readiness
• Act as a key quality representative during regulatory inspections (e.g. HPRA, EMA and international authorities)
• Review and certify batch documentation, deviations, investigations and change controls prior to release
• Provide QP oversight of:
  • Deviations and investigations
  • CAPA
  • Change control
  • OOS/OOT investigations
  • Complaints and recalls
  • Document and record management
• Provide expert guidance on sterile manufacturing, contamination control strategy and aseptic processing
• Support ongoing development and improvement of the Pharmaceutical Quality System (PQS)
• Collaborate with Manufacturing, QC, QA, Regulatory Affairs and Supply Chain to ensure compliant and efficient operations
• Support supplier qualification, third-party oversight and Quality Technical Agreements where required
• Promote a strong quality culture across the site

Required Experience and Skills

• Eligible to act as a Qualified Person (QP) under EU GMP
• Proven experience certifying batches within sterile or aseptic pharmaceutical manufacturing
• Strong working knowledge of EU GMP and wider GxP regulations
• Experience working with regulatory authorities including HPRA and/or other EU agencies
• Demonstrable experience in batch certification and release of sterile medicinal products
• Strong expertise in quality processes including deviations, CAPA, change control and QRM
• Experience supporting and hosting regulatory inspections
• Strong understanding of Annex 1 and contamination control strategies
• Excellent stakeholder engagement and communication skills
• Able to operate effectively in an on-site, hands-on contract role

Working Pattern

On-site (Ireland)

Contract Length

12 months

Rate

Day rate negotiable depending on experience

Location

Ireland

Keywords

Qualified Person | QP | Sterile Manufacturing | Aseptic Processing | EU GMP | Annex 1 | Batch Release | Pharmaceutical | Contract | Regulatory Compliance