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PM Group

International project delivery firm for facilities

Quality Assurance Lead – Commissioning, Qualification and Validation

Regulatory & Quality (Life Sciences)Confirmed live in the last 24 hours
Part-timeLimerick, IrelandNo salary listed

About the Job

Requirements

  • A Bachelor's degree in Engineering, Science, Biotechnology, Pharmacy, or a related discipline is required.
  • At least 8 years of experience within pharmaceutical or biotechnology manufacturing environments is required.
  • Previous experience in Quality Assurance, Validation, Commissioning, Qualification and Validation, or Compliance roles is required.
  • A strong understanding of the FDA, EMA, EU GMP Annex 15, ASTM E2500, GAMP 5, and 21 CFR Part 11 is required.
  • Experience supporting qualification of process equipment, clean utilities, facilities, and computerized systems is required.
  • Experience reviewing validation and qualification documentation within GMP-regulated environments is required.
  • Strong stakeholder management, communication, and problem-solving skills are required.

Responsibilities

  • Lead quality oversight of Commissioning, Qualification and Validation activities onsite.
  • Review and approve CQV documentation, including Validation Master Plans, risk assessments, traceability matrices, IQ/OQ/PQ protocols, and validation summary reports.
  • Support design reviews, Factory Acceptance Tests, Site Acceptance Tests, system turnover, and startup activities.
  • Ensure CQV execution complies with Good Manufacturing Practice requirements, regulatory expectations, and client quality standards.
  • Review and approve deviations, Corrective and Preventive Actions, investigations, and change controls.
  • Partner with Engineering, CQV, Automation, Manufacturing, and Client Quality teams to support project delivery.
  • Support inspection readiness, audits, and regulatory inspections.
  • Drive quality issue resolution and provide guidance on validation and compliance matters.
  • Provide regular quality updates to PM Group and client leadership teams.

About the Company

PM Group

International project delivery firm for facilities

PM Group is a global project delivery firm focusing on architecture, engineering, construction management, and validation services. It designs and delivers complex facilities for sectors including pharmaceuticals and life sciences, advanced technology and data centers, food and agriculture, and energy. The company provides end-to-end project work—from initial design and engineering through construction management and validation—to ensure facilities meet rigorous industry standards. What sets PM Group apart is its employee-owned structure and its international footprint, with offices across Europe, Asia, and the United States, enabling it to coordinate multidisciplinary teams on large-scale projects worldwide. The company’s goal is to ensure safe, compliant, and efficient delivery of complex facilities for its clients, helping them bring critical infrastructure online on time and within scope.

Company size
1,001-5,000
Company stage
Not listed
Total funding
Not listed
Headquarters
Machelen, Belgium
Founded
1973

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