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Quality Assurance Validation Specialist

Job description

Are you an experienced Quality Assurance Specialist with extensive experience in validation of lifecycle documents?

JOB RESPONSIBILITIES

  • Acting as Quality Assurance approver for qualification/validation lifecycle documents.
  • Serving as a quality assurance resource for assessing validation requirements, non-conformance, impact assessments, root cause analysis and implementation of CAPA found during CQV activities.
  • Serving as the Quality SME for all validation activities across the site including but not limited to Steam in Place(SIP), Cleaning Validation & CTU (Controlled temperature Unit) Performance qualification.
  • Providing Quality Assurance Validation support for Steam In Place (SIP) of buffer and media preparation systems, upstream (bioreactors) and downstream equipment trains & Autoclave loads.
  • Providing Quality Assurance Validation support for the Cleaning Validation Program.
  • Cleaning (CIP) cycles/ for buffer and media preparation systems, upstream (bioreactors) and downstream equipment trains, parts washers and supporting process equipment.

JOB REQUIREMENTS

  • 3+ years experience in QA or Engineering within the Biopharma / Pharmceutical industry. 
  • Strong knowledge of relevant cGMPs, regulations and current industry trends.
  • Experience working in regulated environment (GMP, CGMP, GAMP, 21 CFR Part 11)
  • 3+ years of experience in commissioning, qualification, and validation activities in in a regulated environment.
  • Technical knowledge of Cleaning validation/verification, quality systems and regulatory requirements.
  • Experience in review and approval of Cleaning Validation studies.
  • Experience in review of temperature mapping studies. Ex CTU’s, Autoclaves, SIP systems.

For a confidential discussion on this or any other current job opportunity please contact Marcel Skolimowski on 021 4847 138 / marcel@sigmar.ie

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