Info loker Analyst I – Internal Controls – IT – The Kraft Heinz Company – The Kraft Heinz Company
- Understands & implements FDA 21 CFR Part 11 electronic records electronic signatures and EU’s Annex 11 standards.
- Define reviews and approves deliverables related to computerized system.
- Develops computerized system Validation, data Integrity and electronic record / electronic signatures related SOPs and global policies.
- Implementation of computerized system validation activities complies with the sites, Alcon’s policies and with cGxP standards and other observed regulatory guidelines.
- Responsible to assist and support failure investigation and root cause analysis on CSV systems.
- Conduct CSV/DI trainings to generate expertise on site.
- Responsible for leading site e-compliance initiatives.
- Assuring compliant interpretation of regulations, GxP and computerized system, electronic record / electronic signature requirements.
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alamat The Kraft Heinz Company.
