Job Responsibilities:
- Prepare, maintain validation and compliance documentation, validation strategies, testing approach, and define roles and responsibilities for the successful validation of Manufacturing systems.
- Develop and review validation deliverables like Validation Master Plan (VMP), User Requirement Specification (URS), Functional Requirement Specification (FRS), Design/Configuration Specifications.
- Experience with Risk Management (performing risk assessments and using results for determination of test strategies).
- Develop and Execute Installation, Operational, and Performance Qualification (IQ, OQ and PQ) protocols, and prepare a Final Validation Report. Resolve testing problems by modifying testing methods or revising test objectives and standards.
- Ensure the manufacturing system(s) complies with FDA and ISO regulations.
- Provide validation support to migrate GxP data from one system to another system and document the results.
- Thorough knowledge of cGMP regulations like 21 CFR Parts 210 & 211 (GMPs), 820 (Quality) and 21 CFR Part 11 (ERES).
- Track project progress vs schedule; communicate progress on an established team meeting schedule; promptly escalating any challenges/delays that may require additional support to resolve and remain on schedule.
- Develop Validation Summary Report (VSR) to document all the validation deliverables, project deviations and resolutions.
- Ensure all the SDLC phases and validation deliverables are in compliance with FDA and company standards.
- Able to work as a team player, lead a team or accomplish tasks without supervision; Superior written and oral communication skills required.
Qualification :
This position requires a candidate with a minimum of Bachelor’s degree in Industrial Engineering or a closely related field.
Travel : Travel involved to client location(s) within US as needed.
Job Tags : Validation Engineer, VMP, URS, FRS, CS/DS, cGMP, FDA, ISO, 21 CFR Part 11, Part 210, Part 211, Part 820, IQ, OQ, PQ, VSR