Validation Lead with AI knowledge - W2 Position

Only on W2

The following requirement is open with our client.

Client                                     : TCS

Title                                       : Validation Lead with AI knowledge

Location                               :  Raritan, NJ (Onsite)

Duration                              : 12 Months

Rate                                       : $50/hr on W2

Relevant experience     :

Detailed Job Description:

We are looking for an experienced Validation Lead with AI knowledge to manage Computer System Validation (CSV) activities in regulated environments.

Key Responsibilities:

·         Lead Computer System Validation (CSV) activities across the software lifecycle.

·         Develop validation, qualification, migration, and verification strategies for enterprise systems.

·         Ensure validation activities follow quality assurance SOPs and regulatory standards.

·         Participate in business requirement discussions and convert requirements into validation documentation.

·         Generate and maintain Computerized Systems Lifecycle documentation including risk assessments, validation plans, and summary reports.

·         Draft and maintain Standard Operating Procedures (SOPs) and Work Instructions (WIs).

·         Work closely with system users, business stakeholders, technical teams, QA teams, and testing teams to ensure validated systems meet regulatory requirements.

·         Provide validation recommendations and guidance to project stakeholders.

·         Ensure SDLC and CSV qualification activities are conducted according to project timelines.

·         Communicate validation findings to both technical and non-technical stakeholders.

·         Coordinate with global teams and project groups across multiple regions.

·         Provide Hypercare and operational support documentation such as operational runbooks.

·         Lead the validation effort across the project lifecycle.

Must Have Skills:

·         Demonstrated experience in Computer System Validation (CSV).

·         Strong understanding of Software Development Life Cycle (SDLC) and Software Testing Life Cycle (STLC).

·         Experience working with validation tools such as Jira, Micro Focus ALM, and qTest.

·         Knowledge of Agile methodologies including user stories, tasks, and continuous testing practices.

·         Experience supporting AI-based or advanced software solutions in regulated environments.

·         Strong understanding of GxP compliance requirements.

·         Experience implementing validation support for 21 CFR Part 11 in pharmaceutical environments.

·         Experience working with FDA-regulated pharmaceutical or life sciences industries.

Thanks and Regards, 

Goutham Eluri

Technical Recruiter 

ASCII Group LLC. 

38345 W. 10 Mile Rd, Ste.#365; Farmington, MI  48335 

Office:

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