QA Compliance Specialist

1 week ago


Cork, Cork, Ireland beBeevalidation Full time €75,000 - €100,000

Job Overview:

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CQRA Resources is seeking contract QA Validation Specialists for a dynamic project based in Cork.

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The ideal candidate will be responsible for reviewing IQ/OQ/PQ protocols and reports, developing validation protocols and reports to ensure compliance with regulatory requirements, and managing the site Validation Master Plan.

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In addition, they will act as a site contact for vendors, provide QA support for equipment qualification, review and approve protocols and reports, and contribute to the development of User Requirement Specifications.

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They will also author documents that ensure cGMP compliance, perform other related duties or projects, and possess excellent communication and organizational skills.

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Requirements:

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- Bachelor's Degree in a scientific or engineering discipline

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- 2+ years' experience in the pharmaceutical industry with excellent working knowledge of cGMP

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- Experienced in QA Validation activities

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- Extensive experience on writing and approving cGMP documentation

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- Good communicator both verbally and written with strong interpersonal and excellent organizational skills

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Preferred Qualifications:

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Software, Process, Cleaning, Equipment, Facilities, and Utilities Validation knowledge and/or experience is preferable



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