Job Description

Key Roles & Responsibilities: Candidate must be detail oriented as the main job responsibility is authoring in-house CSV documentation and review of documents provided by vendors. Experience in software development lifecycle processes (SDLC), Models, Standards in Pharmaceutical industry. Ability to prepare, review the end-to-end CS validation life cycle deliverables of Manufacturing (HMI, PLC, DCS based) & Lab equipments (GC-Empower, KF Titrino-Tiamo, UV & FTIR -Labsolutions, Stability Chambers-ICDAS etc..). Should have good exposure and hands on experience in 21 CFR Part 11, EU ANNEX 11and GAMP5 guidelines and compliance requirements. Experience in leading (independently) validation for projects and ensure the compliance in systems maintenance activities like Data Backup & restoration, User access management, Audit trail review & periodic review etc. Candidate requires oral and written communication skills as there is a high degree of collaboration required between site stakeholders. Involve in QMS activities related to Computerized Systems and engineering department as applicable. Candidate must have the knowledge in validation of DCS & LIMS. Candidate should have good exposure in preparation of risk management process throughout the life cycle of Computerized systems. Comply with SHE Guidelines, SHE Rules and Regulations. Comply with usage of PPE wherever applicable. Education: Candidate must be a graduate, preferably B. Pharmacy / M. Pharmacy / M.Sc. (with experience), computer science engineering or electronic & communication engineering (with pharma experience).

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