
Senior Quality Assurance Specialist
3 days ago
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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