Pharmaceutical Quality Assurance Manager

2 days ago


County Westmeath, Ireland Matrix Recruitment Group Full time

Matrix Recruitment Group is exclusively partnering with a rapidly growing pharmaceutical start-up in Ireland to hire a Pharmaceutical Quality Assurance Manager.

This is an excellent opportunity to join a dynamic site at a pivotal stage, offering outstanding career progression for the right candidate.

You will play a key role in establishing the quality function alongside the Qualified Person (QP).

The company's parent organisation is based in the US, providing strong support and long-term growth potential.

Key Responsibilities:

  • Ensure compliance with HPRA, EU GMP Annex 11 & 15, FDA, EMA, and other regulatory standards.
  • Support the Qualified Person (QP) in setting up the quality function.
  • Lead validation and qualification of equipment, utilities, facilities, and computerised systems.
  • Develop and execute validation protocols (IQ/OQ/PQ), cleaning validation, and process validation.
  • Oversee the Quality Management System (QMS), maintaining SOPs and work instructions.
  • Conduct internal audits, regulatory inspections, and risk assessments (FMEA).
  • Investigate and close validation deviations, non-conformances, and CAPAs.
  • Provide technical leadership and collaborate with cross-functional teams.
  • Ensure compliance with Good Documentation Practices (GDP) and data integrity standards (21 CFR Part 11, Annex 11).

Requirements:

  • 4 years + experience in pharmaceutical or biotech manufacturing with expertise in validation and quality management.
  • Bachelors or Masters degree in Pharmaceutical Sciences, Engineering, Chemistry, Biology, or a related field.
  • Strong knowledge of GMP, risk-based validation, regulatory audits, and QMS.
  • Essential experience with HPRA and EU GMP Annex 11 & 15.
  • Experience with equipment/facility qualification, computerised system validation, and data integrity compliance.


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