Senior Quality Assurance Specialist

3 days ago


Cork, Cork, Ireland beBeeValidation Full time €55,000 - €70,000
Job Title: Contract QA Validation Specialist

A leading company is seeking a contract Quality Assurance professional to work on an exciting project in Cork. This role offers a unique opportunity to utilize your skills and experience in ensuring the quality of software, equipment, and facilities.

Key Responsibilities:
  • Review and report on IQ/OQ/PQ protocols and reports for software, equipment, and facilities.
  • 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 approve protocols and reports.
  • Review and contribute to the development of User Requirement Specifications.
  • Author documents that ensure 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.
  • Good communication and interpersonal skills.


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