QA Validation Specialist

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QA Resources are looking for a number of contract QA Validation Specialists for an exciting project based in Cork.

Role and requirements:

- Review of IQ/OQ/PQ protocols and reports for software, equipment and facilities and report on executed protocols, as required.
- 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 where applicable (e.g., F.A.T)
- Provide QA support for equipment qualification. Review and approve protocols and reports.
- Review and contribute to the development of User Requirement Specifications.
- Provide a review and approval of all vendor supplied documentation.
- Author documents that ensure cGMP compliance, such as investigations, CAPAs, reports and forms.
- Perform other related duties or projects as assigned.

Experience:

- Bachelor's Degree required 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 on writing and approving cGMP documentation
- Good communicator both verbally and written with strong interpersonal and excellent organizational skills.
- Software, Process, Cleaning, Equipment, Facilities, and Utilities Validation knowledge and /or experience is preferable.

Interested candidates should submit an updated CV to enquiries@qaresources.com

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