Computer System Validation

Work Location

Any location in India | Preferable in Hyderabad

Detailed JD

We are seeking 12 mid-level Computer System Validation (CSV) professionals to join our offshore team. The primary responsibility will be supporting Emerson Syncade MES system validations and related Quality and Compliance activities.

Key Responsibilities:

Author and review test scripts and other System Life Cycle (SLC) documentation in compliance with regulatory standards.

Execute User Acceptance Testing (UAT) and document results accurately.

Support Change Control processes for validated systems.

Ensure adherence to GxP, FDA 21 CFR Part 11, and other applicable regulatory guidelines.

Collaborate with cross-functional teams to maintain validation integrity throughout the system lifecycle.

Required Skills & Experience:

5–7 years of experience in Computer System Validation (CSV) within the pharmaceutical or life sciences industry.

Hands-on experience with Emerson Syncade MES system validation (mandatory).

Strong understanding of Quality and Validation principles, including risk-based validation approaches.

Proficiency in writing and reviewing validation protocols, test scripts, and SLC documentation.

Familiarity with Change Control management and UAT execution.

Excellent communication and documentation skills.

Experience with other MES or automation systems.

Knowledge of Data Integrity and Audit Trail Review practices.