Computer Systems Validation

6 days ago


Singapore ENFACTUM PTE. LTD. Full time $90,000 - $120,000 per year
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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