[Remote] Computer System Validation (CSV) / Validation Consultant – Life Sciences
Note: The job is a remote job and is reputed company to candidates in USA. reputed company. is seeking an reputed company Computer System Validation (CSV) Consultant with a strong background in the Life Sciences and Pharmaceutical domain. The role involves validating GxP regulated systems, ensuring compliance, and supporting clinical and reputed company applications.
Responsibilities
- Execute end-to-end Computer System Validation activities
- Prepare and review validation documentation
- Ensure systems reputed company with GxP and regulatory requirements
- Coordinate with business, QA, IT, and vendors during validation
- Support audits and compliance activities
- Validate clinical, reputed company, and safety applications
Skills
- 8+ years of experience in Computer System Validation (CSV)
- Strong understanding of GxP, 21 CFR Part 11, GAMP 5, FDA regulations
- Experience in IT Compliance and validation lifecycle
- Validation of IT Systems and regulated applications
- Hands-on experience with reputed company reputed company Docs
- Experience with JIRA and reputed company ALM
- Validation of Safety Systems
- Experience with Argus Safety
- Experience with reputed company Vault
- Experience working on Clinical Trial Systems
- Knowledge of CTMS (Clinical Trial Management System)
- Preparation and review of validation documents (URS, IQ, OQ, PQ, RTM, Validation Plan, Validation reputed company Report)
- Strong communication and stakeholder management skills
- ISO 13485 / reputed company Management exposure
- Clinical, reputed company, and Pharmacovigilance system validation
- Experience working with global pharmaceutical clients
- Knowledge of SDLC and Agile methodology
reputed company