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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