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Angela McCauley
Life Science

+353 87 696 0951
[email protected]
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Details

Senior QA Specialist - Technical Transfer


Reference:AMC4171 Location: Dublin South
Qualification:DegreeExperience:See description
Job Type:Fixed Term ContractSalary: Not Disclosed
May be suitable for: Validation Specialist

Senior Quality Assurance Specialist – Tech Transfer/NPI
12 month contract
South Dublin - Hybrid role
AMC4171


Position Summary:
We are seeking an experienced Quality Assurance Professional to provide quality direction and oversight for activities related to Technology Transfer, New Product Introductions (NPI), and Product Lifecycle Management (LCM).

This role requires a strong focus on technical transfer processes, including QA leadership in the preparation and execution of Process Performance Qualification (PPQ) and validation activities within a pharmaceutical sterile manufacturing environment.

The ideal candidate will have 10+ years of industry experience including proven experience in technical transfer, PPQ execution and lifecycle management


Key Responsibilities:

  • Technical Transfer and NPI Oversight:
    Provide overall quality direction for processes and procedures associated with technology transfer, NPI, and product lifecycle changes. Act as the Quality point of contact and decision-maker during technology transfer and PPQ execution activities, ensuring compliance with regulatory and company standards.
  • Validation and Documentation:
    Review and approve validation documentation, including Design Specifications (DS), User Requirements Specifications (URS), and Quality Risk Assessments (QRAs), as well as Validation Plans, Protocols (IQ, OQ, PQ), and associated reports.
  • Risk Management and Compliance:
    Conduct risk assessments and develop mitigation strategies for potential challenges in process transfers. Provide input and quality oversight for change control development and implementation, ensuring timely and robust execution of change controls and CAPA records.
  • Process and Product Support:
    Review and approve Bill of Materials (BOMs), Master Batch Records (MBRs), and production recipes. Collaborate with cross-functional teams to optimize processes and ensure successful scale-up and commercial manufacturing.
  • Documentation and SOPs:
    Write, review, and approve Standard Operating Procedures (SOPs) in alignment with company policies.

Requirements
  • 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 technical transfer, PPQ execution, and lifecycle management.
  • Strong understanding of validation principles and regulatory requirements for process validation (FDA, EMA guidelines).
  • 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.
  • Strong critical thinking and problem-solving abilities.

Additional Skills:
  • Familiarity with Quality by Design (QbD).
  • Proficiency in statistical analysis tools (e.g., Minitab, JMP) is a plus.
  • Team-oriented mindset with the ability to thrive in a collaborative decision-making culture.

Apply today or get in touch with Angela McCauley at Life Science Recruitment for more information