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Rachel Kent
Life Science

+353 87 427 8808
[email protected]
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Details

Senior Quality Assurance Specialist


Reference:RK5297 Location: Dublin
Qualification:DegreeExperience:5-7 Years
Job Type:Fixed Term ContractSalary: Not Disclosed
May be suitable for: QA Specialist

Senior Quality Assurance Specialist
Remote
RK5297
Contract 12 months
Dublin



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 understanding of Quality requirements associated with aseptic manufacturing, as well as an excellent understanding of C & Q / Validation and Technical Transfer requirements. The desired candidate should have a proven track record in QA leadership, and be comfortable working as part of a cross functional team.



Key Responsibilities:

  • Provide overall quality direction for processes and procedures associated with all aspects of new equipment introduction, including Computerised System Validation
  • Act as the Quality point of contact and decision-maker for C & Q / Validation execution activities, ensuring all activities comply with regulatory and company standards.
  • Lead Quality review and approval of validation documentation associated with new facilities and new product introduction
  • Lead QA review and approval of SAP BOMs, MBRs and recipes as applicable.
  • Partner cross-functionally with PD, Engineering, and Operations teams to ensure all NPI activities are compliant with regulatory and Site Quality Requirements.
  • Provide Quality Direction and input for Change Controls, CAPAs, and Deviation Investigations.
  • Support Inspection Readiness and Regulatory Audits, representing QA for Validation and NPI areas.
  • Conduct risk assessments and develop mitigation strategies for potential challenges in equipment / product introduction.
  • Provide input and Quality Oversight for change control development and implementation.
  • Ensure timely and robust implementation of change controls and CAPA records.
  • Write, review, and approve Standard Operating Procedures (SOPs) in alignment with company policies.
  • Ensure all activities align with company’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-related discipline.
  • Minimum of 7 years’ relevant experience in the pharmaceutical or biotechnology industry as a Subject Matter Expert providing overall quality direction and oversight for key functional areas (i.e. Process Development, Validation, Manufacturing)
  • In-depth knowledge of applicable regulatory requirements and experience with regulatory inspections.
  • Experience working in aseptic operations, relating to vial and syringe filling.
  • Understanding of principles of Validation and New Product Introduction
  • Proven experience in Quality Systems (change control, non-conformance, corrective and preventative actions)


If interested in this posting please feel free to contact Rachel Kent at Life Science Recruitment for further information.