Job Title: Contract QA Validation Specialist
A leading company is seeking a contract Quality Assurance professional to work on an exciting project in Cork. This role offers a unique opportunity to utilize your skills and experience in ensuring the quality of software, equipment, and facilities.
Key Responsibilities:
* Review and report on IQ/OQ/PQ protocols and reports for software, equipment, and facilities.
* 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.
* Provide QA support for equipment qualification.
* Review and approve protocols and reports.
* Review and contribute to the development of User Requirement Specifications.
* Author documents that ensure cGMP compliance, such as investigations, CAPAs, reports, and forms.
Requirements:
* Bachelor's Degree in a scientific or engineering discipline.
* Minimum 2+ years' experience in the pharmaceutical industry with excellent working knowledge of cGMP.
* Experience in QA Validation activities.
* Extensive experience in writing and approving cGMP documentation.
* Good communication and interpersonal skills.