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5 - 10 years

10 - 18 Lacs

Hyderabad

Work from Office

Good understanding of the GAMP 5, 21 CFR Part 11, EU GMP Annex 11, ICH Quality and other regulatory guidelines Review requirements, specifications, and technical design documents to provide timely and meaningful feedback. Experience in Validation life cycle of regulated projects GxP Awareness including Good Documentation. Practice Knowledge on Change control and Deviations, GAMP Categorization, Protocol Preparation, Vendor Evaluation. Good knowledge on pharma regulatory compliance processes and regulations Ensure all defined Process Engineering phases are reviewed, verified & defect removal is done. Take responsibility for creating the Project Validation Plan based on the criticality of the proposed system, in consensus with the vendor, based on their Quality Systems. Performing Internal Audits as per annual inspection plan for GxP/GMP compliance and quality review. Capture the lessons and best practices in projects and suggest process improvements at the organization level. Conduct process related trainings and its tracking. Practice on Review for Requirement Specifications. (URS,FS and DS) Ensure that all sources are baseline and stored centrally in the central repository and local library of the project. Conduct baseline audits and reviews. Troubleshooting / investigating project defect database and bugs are classified. Establishing and implementing corrective and preventive actions and process improvements initiatives for CSV projects. Experience in SDLC phases & Software Release strategy. Candidate should have work experience in software & Pharma industry.Role & responsibilities

Posted 3 months ago

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