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Rachel Kent
Life Science

+353 87 427 8808
[email protected]
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Details

Quality Assurance Senior Specialist (Hybrid role)


Reference:RK34629 Location: Dublin
Qualification:DegreeExperience:See description
Job Type:Fixed Term ContractSalary: Not Disclosed
May be suitable for: QA Specialist, QA Supervisor, QA Validation Specialist

We’re currently recruiting for an exciting opportunity with an award-winning Pharmaceutical organization based in Dublin. This is an excellent position for anyone who is looking to join a leading multinational who are one of the best at what they do.

This role requires a strong focus on QA leadership in the design, installation, and qualification of facility, equipment, utility, and process systems, with particular emphasis on Validation Oversight.

Key Responsibilities:

  • Provide QA leadership during facility design, and layout
  • Provide overall quality direction for processes and procedures associated with project
  • Lead QA review and approval of URS, DS, QRAEs, and IQ/OQ/PQ protocols and reports.
  • Act as the Quality point of contact and decision-maker during validation execution activities, ensuring all activities comply with regulatory and company standards.
  • Ensure Computerised System Validation (CSV) meets regulatory and data integrity standards.
  • Ensure validation documentation is robust, traceable, and inspection-ready.
  • Drive risk assessments and mitigation strategies for new equipment and processes.
  • Provide QA oversight for Change Controls, CAPAs, and Deviation Investigations.
  • Ensure all activities align with Amgen’s safety standards, SOPs, and regulatory expectations.
  • Support a safe working environment by adhering to all environmental health and safety practices, rules, and regulations.
Education and Experience:
  • University degree in a Science or Engineering-related discipline.
  • Minimum of 10 years of relevant experience in the pharmaceutical or biotechnology industry.
  • Proven expertise in facility startup and Quality Oversight of Validation activities.
  • Experience with change control, non-conformance resolution, and CAPA implementation.
  • Excellent organizational, communication, and collaboration skills.
  • Ability to work independently with minimal supervision and operate effectively across functional boundaries.
  • Familiarity with Quality by Design (QbD).
  • Proficiency in statistical analysis tools (e.g., Minitab, JMP) is a plus.
If interested in this posting please feel free to contact Rachel Kent at Life Science Recruitment for further information.