CSV Consultant (Computerized System Validation)
Seeking a consultant with experience in Computerized System Validation (CSV) to support regulatory and quality compliance across IT systems.
Mandatory Skills
* CSV
* FDA regulations 21 CFR Part 11, 21 CFR Part 820, GxP Regulations, GAMP 5, SOX Regulations, EU Annex 11, EU Annex 22, ISO 9001, ITIL processes
* Experience with document management tools such as Valgenesis, Veeva Vault
Key Responsibilities
* Collaborate with IT stakeholders to conduct regulatory risk assessments of quality systems, solutions, and services.
* Review validation deliverables, including Requirements Specifications (URS/FS), Test Protocols, and Final Reports.
* Provide quality support for projects and application and infrastructure changes.
* Support audit and inspection readiness of regulated solutions.
* Guide IT stakeholders on documents and records management.
* Recommend actions to close compliance gaps and improve processes.
* Ensure compliance with SOPs, policies, and procedures.
* Conduct and coordinate periodic reviews of GxP applications.
* Perform access roster reviews, audit trail reviews, and finalize review reports.
Key Words
* CSV Computerized System Validation
* GxP
* Regulatory System
* Pharmaceutical Area
What do we offer?
* Health insurance
* Life insurance
* Gympass
* TCS Cares – free 0800 providing psychological, legal, social and financial assistance to associates
* Partnership with SESC
* Reimbursement for certifications
* Free TCS Learning Portal – online courses and live training
* International experience opportunity
* Discount partnership with universities and language schools
* Bring Your Buddy – referral bonus program
* TCS Gems – recognition for performance
* Xcelerate – free mentoring career platform
Tata Consultancy Services is an equal opportunity employer. We are committed to diversity & inclusion and provide equal opportunity to all candidates who meet our required knowledge & competency needs, irrespective of socio-economic background, race, color, national origin, religion, sex, gender identity/expression, age, marital status, disability, sexual orientation or any other characteristic. We encourage anyone interested to build a career in TCS to participate in our recruitment & selection process.
At Tata Consultancy Services we promote an inclusive culture, always work for equity across gender, people with disabilities, LGBTQIA+, religion, race, ethnicity. Our opportunities are based on these principles.
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