Roles and Responsibilities Conduct CSV activities such as risk assessment, gap analysis, and validation planning. Perform computer system validation (CSV) activities according to industry standards like GAMP5 and 21 CFR Part 11. Ensure compliance with EU Annexure 11 requirements for software validation. Collaborate with cross-functional teams to identify and resolve issues related to HPLC, LIMS, EMS, BMS systems. Develop test scripts and execute tests using V-model approach. Preparation, Execution, Compilation and approval of below documents (Not limited to) 1) User requirement specifications 2) Validation Plan 3) GxP Assessment 4) System Design Specification 5) Risk Assessment 6) Network (Infra) Qualification 7) Installation Qualification protocol 8) Operational Qualification 9) Performance Qualification 10) Traceability matrix 11) Validation summary report
IT- qualification , QMS in Pharma - Implement IT policies and coordinate with vendor ,Perform periodic maintenance of GxP system , Network configurations & infrastructure project , Cloud computing (SAAS, PAAS), backup, and user Management Free meal House rent allowance Travel allowance
Role & responsibilities Review source documentation for master data objects such as laboratory methods and analysis Create/ build master data objects in the LIMS, including test methods, specifications, sample plans, and instruments Ensure data consistency, accuracy, and compliance with internal SOPs and external regulatory requirements (e.g., FDA, ISO, GxP) Support LIMS validation activities, including documentation and testing. Troubleshoot and resolve data-related issues within the LIMS Collaborate with a team of master data builders working across various sites for the LIMS deployment Preferred candidate profile 2+ years of experience working with LIMS platforms (Ideally, Caliber) Strong understanding of laboratory operations and data management principles Experience with master data configuration for LIMS systems Excellent attention to detail and problem-solving skills Strong communication and collaboration abilities Experience in a regulated industry (e.g., pharmaceuticals, biotech, food safety) Knowledge of GxP, 21 CFR Part 11, and other regulatory frameworks Bachelors degree in Life Sciences, Information Technology, or a related field