Computer Systems Validation (CSV) Engineer
ENFACTUM PTE. LTD.
4 days ago
Posted date4 days ago
N/A
Minimum levelN/A
EngineeringJob category
EngineeringResponsibilities
Requirements
- 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.
JOB SUMMARY
Computer Systems Validation (CSV) Engineer
ENFACTUM PTE. LTD.
Singapore
4 days ago
N/A
Full-time
Computer Systems Validation (CSV) Engineer