QA Compliance Professional

2 days ago

Cork, Cork, Ireland beBeeValidation Full time €60,000 - €80,000

Job Description:

We are seeking a skilled QA Validation Specialist to join our team in Cork. This exciting project involves reviewing IQ/OQ/PQ protocols and reports for software, equipment, and facilities, and reporting on executed protocols as required.

The successful candidate will be responsible for developing validation protocols and reports to ensure compliance with regulatory requirements, managing the site Validation Master Plan, and acting as a site contact for vendors.

Additionally, they will provide QA support for equipment qualification, review and approve protocols and reports, contribute to developing User Requirement Specifications, and author documents ensuring cGMP compliance.

  • Review and report on IQ/OQ/PQ protocols and reports
  • Develop validation protocols and reports
  • Manage the site Validation Master Plan
  • Act as a site contact for vendors
  • Provide QA support for equipment qualification
  • Review and approve protocols and reports
  • Contribute to developing User Requirement Specifications
  • Author documents ensuring cGMP compliance

Requirements:

To be considered for this role, candidates must have a Bachelor's Degree in a scientific or engineering discipline and at least 2+ years' experience in the pharmaceutical industry with excellent working knowledge of cGMP.

They should also have extensive experience writing and approving cGMP documentation, good communication skills both verbally and written, strong interpersonal and organizational skills, and preferably, knowledge and/or experience in Software, Process, Cleaning, Equipment, Facilities, and Utilities Validation.

Contact Information:

Candidates who meet the requirements and are interested in this opportunity should submit an updated CV for consideration.

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