
QA Compliance Specialist
1 week ago
Job Overview:
">CQRA Resources is seeking contract QA Validation Specialists for a dynamic project based in Cork.
">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.
">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.
">They will also author documents that ensure cGMP compliance, perform other related duties or projects, and possess excellent communication and organizational skills.
">Requirements:
">- Bachelor's Degree in a scientific or engineering discipline
">- 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
">Preferred Qualifications:
">Software, Process, Cleaning, Equipment, Facilities, and Utilities Validation knowledge and/or experience is preferable
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