CSV Validation Specialist
The CSV Validation Specialist is the subject matter expert within the Validation team, responsible for leading validation strategies for major capital projects.
Main Responsibilities:
* To develop and review validation plans, protocols, and reports ensuring compliance with global and local quality standards.
* Represent Validation at internal and external audits by regulatory agencies, including HPRA and FDA.
* To create and review CSV project documentation, including user requirement specifications, validation protocols, reports, etc., and standard operating procedures.
The successful candidate will have hands-on experience in validation execution, solid knowledge of GxP, FDA 21 CFR Part 11, EU Annex 1, and ISPE GAMP 5 guidelines.
Essential Skills and Qualifications:
* At least 2 years of equipment qualification experience, including GAMP, equipment life-cycle FAT, SAT, DQ, QRM, IQ, OQ, PQ.
* Experience performing data integrity assessments and data mapping.
* Excellent technical writing and analytical skills.
* Familiarity with cGMPs and federal guidelines.
Benefits:
This role offers a unique opportunity to work on complex validation projects, collaborate with cross-functional teams, and contribute to the development of industry-leading quality standards.