Lead CSV IT Validation
Apply NowCompany: Tata Consultancy Services
Location: Piscataway, NJ 08854
Description:
Technical/Functional Skills
Roles & Responsibilities
Salary Range-$110,000-$130,000 a year
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- Knowledgeable in 21 CFR Part 11, Annex 11, and GAMP 5
- Updates validation procedures, including change control, training, and audits, to ensure the maintenance of system validation.
- Writes and reviews technical validation documents (e.g., validation plan, URS, FRS, Risk Assessment, Traceability Matrix, IQ/OQ/PQ/OPQ protocol, report, etc.)
- Assists in system validation project activities (e.g., writing protocols, reviewing/approving test scripts, drafting validation reports, etc.)
Roles & Responsibilities
- Conduct validation assessments for computer systems, software applications, and electronic records in compliance with healthcare regulatory requirements.
- Develop and execute validation protocols, test scripts, and validation plans for computer systems used in the healthcare industry.
- Collaborate with cross-functional teams, including IT, Quality Assurance, and Regulatory Affairs, to ensure alignment with validation requirements.
- Perform risk assessments to identify potential vulnerabilities in computer systems and implement strategies for risk mitigation.
- Provide expertise on validation best practices, industry standards, and regulatory expectations to internal teams.
- Maintain accurate and up-to-date validation documentation, including validation reports, change control records, and standard operating procedures.
- Participate in internal and external audits related to computer system validation and respond to audit findings as necessary.
- Keep abreast of industry trends, regulatory updates, and technological advancements to enhance the validation process.
Salary Range-$110,000-$130,000 a year
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