Computerized Systems Validation (CSV) & Data Integrity Lead
at
GE HealthCare
victoria, New South Wales, Australia
-
Full Time
Start Date
Immediate
Expiry Date
06 Dec, 26
Salary
0.0
Posted On
07 Sep, 26
Experience
0 year(s) or above
Remote Job
Yes
Telecommute
Yes
Sponsor Visa
No
Skills
Industry
Pharmaceutical Manufacturing
Description
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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