QA Validation Specialist

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 [email protected]