Validation Specialist

2 weeks ago

Cork, Cork, Ireland beBeeValidation Full time €60,000 - €75,000

Key roles and responsibilities for this position include:

Job Description
  • Review and report on IQ/OQ/PQ protocols and reports as needed.
  • Develop validation protocols and reports to ensure compliance with regulatory requirements.
  • Assist in the management of the site Validation Master Plan and its timely execution.
  • Act as a site contact for vendors where required, including off-site meetings.
  • Provide QA support for equipment qualification, review, and approval of protocols and reports.
  • Contribute to the development of User Requirement Specifications.
  • Review and approve vendor-supplied documentation.
  • Author documents ensuring cGMP compliance, such as investigations, CAPAs, reports, and forms.

Requirements:

  • Bachelor's Degree in a scientific or engineering discipline.
  • Minimum 2+ years' experience in the pharmaceutical industry with excellent working knowledge of cGMP.
  • Experience in QA Validation activities.
  • Extensive experience in writing and approving cGMP documentation.
  • Excellent communication and interpersonal skills.
  • Strong organizational skills.
  • Software, Process, Cleaning, Equipment, Facilities, and Utilities Validation knowledge and/or experience preferred.

We seek highly skilled professionals who can work effectively in a team environment and provide high-quality deliverables under tight deadlines.

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