We are seeking experienced QA Validation Specialists for an exciting project in Cork.
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 managing the site Validation Master Plan and its timely execution.
* Act as a site contact for vendors and provide QA support for equipment qualification.
* Review and approve protocols and reports, as well as contribute to User Requirement Specifications.
* Author documents ensuring cGMP compliance, such as investigations, CAPAs, reports, and forms.
The successful candidate will possess excellent communication skills, both verbal and written, with strong interpersonal and organizational skills.
Experience in writing and approving cGMP documentation is essential. Software, Process, Cleaning, Equipment, Facilities, and Utilities Validation knowledge and/or experience is preferable.
We are looking for candidates who can demonstrate their ability to work independently and as part of a team.