Job Description :
Role: Computer System Validation

Location: Raynham, MA

Duration: Contract





Job Description –




B.S. /M.S. in IT/Engineering or equivalent with 5+years of experience in Computer System Validation with Life sciences – Pharma/ Medical Devices processes / projects especially-21 CFR part 11
Coordinate between Buyer stakeholders, Subject Matter Experts (“SME/s”)
Interact with Buyer, understand their requirement & provide delivery team with client expectations
Work closely with project leaders on collaborating and collecting the right inputs
Create and update documents relating to CSV activities per SDLC methodology.
Draft and maintain cGxP system lifecycle documentation, including validation plans, User Requirements (URS), Functional and Design Specifications, Testing Protocols (IQ/OQ/PQ), traceability matrix, validation reports, SOPs, change control documentation, risk assessments, and validation summary reports.
Reviewing completed protocols for completeness, cGxP compliance and data acceptability; compiles final data-pack.


Responsible for tracking and maintaining deliverables





Regards

Kapil Verma

InfiCare Technologies| 22375 Broderick Drive #225 Dulles VA 20166 |

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Servicing our clients since 2001    MBE/ DBE Certified in VA, MD, PA, NJ, NC, CA 

IT Services * Application Development * Mobility Solutions

Escalation Contact: Tarender Singh