Computer Systems Validation

3 days ago


Singapore ENFACTUM PTE. LTD. Full time

Responsibilities Develop and implement strategies for the validation of computer systems in compliance with domestic and international regulations. Prepare and maintain all necessary validation documents, including validation master plans, validation plans, and risk assessments. Execute validation protocols and prepare validation summary reports. Manage change control for validated systems and perform impact assessments for changes to validated systems. Conduct training on CSV principles and procedures. Ensure compliance with all relevant regulations, including GxP, GAMP5, ERES, and Data Integrity. Collaborate with cross-functional teams to ensure smooth execution of validation activities. Requirements Experience in a CSV role within the pharmaceutical industry is a MUST. Strong knowledge of GMP, GAMP5, ERES, and Data Integrity. Excellent communication and organizational skills.



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