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PM Group

QA Lead (CQV)

PM Group Limerick, Munster, Ireland

Business Consulting and Services · 1,001-5,000 employees

Oct 21
qa Senior (5-10 yrs) Part-time Ireland
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About the role

Lead quality oversight of onsite commissioning, qualification, and validation activities, including review and approval of validation plans, protocols, reports, and quality records. Support design reviews, testing, system turnover, startup, audits, and inspections while partnering with project and client teams to resolve quality issues and ensure GMP compliance.

What they look for

Quality Assurance Commissioning, Qualification, And Validation GMP Compliance Validation Documentation Review Risk Assessment Deviation Management CAPA Management Change Control Audit Readiness Regulatory Inspection Support Process Equipment Qualification Clean Utilities Qualification Computerized Systems Qualification Stakeholder Management Communication Problem-Solving

Requirements

Requires a bachelor's degree in engineering, science, biotechnology, pharmacy, or a related discipline, plus at least eight years of experience in pharmaceutical or biotechnology manufacturing. Candidates should have experience in quality assurance, validation, CQV, or compliance, knowledge of relevant GMP and regulatory standards, and experience qualifying equipment, utilities, facilities, and computerized systems.

Full description

Overview

PM Group is a leading international engineering, architecture, project and construction management firm. With a network of offices in Europe, Asia and the US and a multi-discipline team of over 4000+ people, we deliver complex capital projects in the life sciences, food and beverages, mission critical/ICT, advanced manufacturing, energy and environmental sectors.

Due to our ongoing success securing large-scale projects we now have a requirement for a Quality Lead (CQV) based onsite with us in Limerick.

Who Are We

PM Group is an employee owned, international project delivery firm. We are world leaders in the pharma, food, medtech and mission critical sectors. From our network of offices in Europe, Asia and the US, we work with the world's leading organisations. We are focused on growing a sustainable business centred around our people, our clients and trade partners.

Responsibilities

  • Lead Quality oversight of Commissioning, Qualification and Validation (CQV) activities onsite.
  • Review and approve CQV documentation including:
  • Validation Master Plans (VMPs)
  • Risk Assessments
  • Traceability Matrices
  • IQ/OQ/PQ Protocols
  • Validation Summary Reports
  • Support design reviews, FATs, SATs, system turnover and startup activities.
  • Ensure CQV execution complies with GMP requirements, regulatory expectations and client quality standards.
  • Review and approve deviations, CAPAs, 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.

Qualifications

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

Why PM Group?

As an employee-owned company, we are inclusive, committed and driven. Corporate Responsibility and Sustainability are at the heart of our business strategy.

Inclusion and Diversity are core to our culture and values. Wherever we work, we commit to a culture of mutual respect and belonging by building a truly inclusive workplace rich in diverse people, talents and ideas. Valuing the contributions of all our people and respecting individual differences will sustain our growth into the future.

PM Group is committed to ensuring our hiring process is fair and accessible to all and will provide candidates with disabilities with reasonable accommodations required to participate in the recruitment process. If you require any assistance in this regard, please let us know.

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