Lowongan Kerja (Loker) Principal Engineer – CSV Batam 2023 –
Principal Engineer – CSV
Batam, Batam City, Riau Islands
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.
Working in accordance with the HSE Manual and documented procedures, and reporting HSE issues to the respective area owners.
Responsible for leading site e-compliance initiatives. Assuring compliant interpretation of regulations, GxP and computerized system, electronic record / electronic signature requirements