- 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.
- 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.
Computer Systems Validation - Singapore - COGNIZANT TECHNOLOGY SOLUTIONS ASIA PACIFIC PTE. LTD.
Found in: Talent SG 2A C2 - 2 weeks ago
Description
Roles & ResponsibilitiesWe are are looking to hire Computer Systems Validation (CSV) Engineer to join our MES team working at our client site, a pharmaceutical MNC.
Responsibilities
Requirements
Cognizant (Nasdaq: CTSH) engineers modern businesses. We help our clients modernize technology, reimagine processes and transform experiences so they can stay ahead in our fast-changing world. Together, we're improving everyday life. See how at or @cognizant.
Tell employers what skills you haveMES
GxP
Pharmaceutical Industry
Computer Systems Validation
CSV files
GMP
Compliance
Change Control
Life Science Industry
Life Sciences
Manage Change