CSV SPECIALIST (COMPUTER SYSTEM VALIDATION) @ ANI SYSTEMS
We are seeking a highly skilled and dedicated CSV Specialist (Computer System Validation) to join our team in Ahmedabad, Gujarat, on a full-time basis. The ideal candidate will be responsible for independently managing and executing the end-to-end CSV lifecycle, from developing User Requirement Specifications (URS) to finalizing Validation Summary Reports (VSR). This role requires a professional who can take complete ownership of assigned projects, ensuring that all computer systems used in the pharmaceutical and life sciences environment are fully compliant with international regulatory standards. In addition to technical execution, the successful candidate will perform comprehensive risk assessments, handle deviations, and implement Corrective and Preventive Actions (CAPA) as necessary.
You will be expected to coordinate seamlessly with cross-functional teams and clients to deliver projects within established timelines. Expertise in 21 CFR Part 11, GAMP 5, and Data Integrity is essential for success in this position. This is a fantastic opportunity for an experienced professional to grow within a dynamic and regulated industry while maintaining high standards of documentation and quality control. The position requires strong communication skills and the ability to work independently in a fast-paced environment while meeting all regulatory and project-specific deliverables. Possible work locations include Ahmedabad and the surrounding Gujarat region as part of project site requirements.
You will be expected to coordinate seamlessly with cross-functional teams and clients to deliver projects within established timelines. Expertise in 21 CFR Part 11, GAMP 5, and Data Integrity is essential for success in this position. This is a fantastic opportunity for an experienced professional to grow within a dynamic and regulated industry while maintaining high standards of documentation and quality control. The position requires strong communication skills and the ability to work independently in a fast-paced environment while meeting all regulatory and project-specific deliverables. Possible work locations include Ahmedabad and the surrounding Gujarat region as part of project site requirements.
Key Requirements
Hands-on experience in Computer System Validation (CSV) lifecycle management.
In-depth knowledge of 21 CFR Part 11 and GAMP 5 regulations.
Proficiency in Data Integrity principles within a regulated environment.
Experience working in the pharmaceutical or life sciences industry.
Strong technical writing and documentation skills for validation protocols.
Ability to perform risk assessments and ensure ongoing regulatory compliance.
Proven track record of handling deviations, CAPA, and change controls.
Excellent communication skills for coordinating with cross-functional teams and clients.
Ability to manage project timelines and deliverables independently.
Experience in preparing and reviewing User Requirement Specifications (URS) and Validation Summary Reports (VSR).