Write, review and execute Validation Protocols and Reports (for Equipment, software /automation, and enterprise software systems) ensuring compliance to all relevant global and local quality and validation procedures/standards
Review change controls and assess impact of changes that affect validated systems and define validation requirements
Represent Validation at both internal and external audits by regulatory agencies, including HPRA and FDA.
Generation and review of CSV project documentation (User Requirement Specifications, validation protocols, reports etc.) and Standard Operating Procedures.
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