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Qa Validation Specialist

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Cork, Ireland Qa Resources Full time

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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
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