QA Validation Experts Wanted

21 hours ago

Cork, Cork, Ireland beBeeValidation Full time €80,000 - €95,000

Contract QA Validation Specialists Needed


Join us for an exciting opportunity to work on a contract basis as a QA Validation Specialist. This project is based in Cork and offers the chance to collaborate with a dynamic team.


Job Description

As a QA Validation Specialist, you will be responsible for reviewing IQ/OQ/PQ protocols and reports for software, equipment, and facilities, and reporting on executed protocols as required. You will also develop validation protocols and reports to ensure compliance with regulatory requirements.


Key Responsibilities
  1. Review of IQ/OQ/PQ protocols and reports for software, equipment, and facilities.
  2. Developing validation protocols and reports to ensure compliance with regulatory requirements.
  3. Assisting in the management of the site Validation Master Plan and its timely execution.
  4. Acting as a site contact for vendors where required, including off-site meetings.
  5. Providing QA support for equipment qualification, review and approval of protocols and reports.
  6. Review and contributing to the development of User Requirement Specifications.
  7. Providing a review and approval of all vendor-supplied documentation.
  8. Authorizing documents that ensure cGMP compliance, such as investigations, CAPAs, reports, and forms.

Requirements
  • Bachelor's Degree in a scientific or engineering discipline.
  • Minimum of 2+ years' experience in the pharmaceutical industry with excellent working knowledge of cGMP.
  • Experienced in QA Validation activities.
  • Extensive experience in writing and approving cGMP documentation.
  • Good communication skills both verbally and written with strong interpersonal and excellent organizational skills.

Benefits

This contract position offers the opportunity to work on a high-profile project with a dynamic team. If you are a motivated and experienced QA professional, we encourage you to apply.


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