Manufacturing Ops Qualified Person

2 weeks ago

Galway, Galway, Ireland Steripack Full time

Qualified Person / Responsible Person – Biopharmaceutical Industry
Location:Dublin
Sector: Pharmaceutical / Clinical Supply Chain
Type: Full-Time | Contract

We are recruiting on behalf of a leading biopharmaceutical company for a Qualified Person (QP) / Responsible Person (RP) to play a pivotal role in ensuring the quality, compliance, and regulatory readiness of clinical supply chain operations.

Key Responsibilities:

  • QP certification and batch release of clinical supplies

  • Serve as RP under a Wholesale Distribution Authorisation (WDA) for Pre-Approval Access

  • Lead and support GMP/GDP inspections and audits

  • Advise stakeholders on quality improvements, compliance, and risk mitigation

  • Maintain and update the Site Master File and Manufacturer's Authorisation

  • Ensure timely communication of quality issues to partners and leadership

  • Review and approve SOPs and procedural documents

  • Contribute to global audit planning and continuous improvement programs

  • Stay ahead of global regulatory changes and integrate them into quality systems

  • Influence external quality standards through engagement with regulators and industry bodies

Candidate Profile:

  • Degree in science, engineering, or related discipline

  • Eligible to act as a Qualified Person (QP) under EU regulations

  • Experience as a Responsible Person (RP) under a WDA is preferred

  • Minimum 10 years in the pharmaceutical/biopharma industry

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