Loading open roles
UpMan Placements Private Limited
Sr. Officer
UpMan Placements Private Limited · posted 2 months ago
Goainformation technology
About the role
| Key Deliverables | Skill Requirements |
| Perform end-to-end CSV activities for GxP systems. | Strong documentation and technical writing skills |
| Prepare and review URS, FS, RA, IQ, OQ, and PQ documents. | Experience with validation tools and templates |
| Ensure compliance with GxP, 21 CFR Part 11, Annex 11, and Data Integrity requirements. | Knowledge of SDLC and validation lifecycle |
| Support audit trail review, deviation investigation, and CAPA activities. | Good analytical and problem-solving skills |
| Manage validation lifecycle for MES, LIMS, ERP, QMS, and other applications. | Familiarity with audit processes |
| Participate in change control, impact assessment, system implementation, and upgrades. | Experience with MES, LIMS, SAP, or QMS |
| Support regulatory audits including USFDA, MHRA, and WHO inspections. | Exposure to automation systems and PLC integration |
| Maintain RTM and validation documentation as per SOPs and QMS. | Understanding of cybersecurity in GxP systems |
| Follow risk-based validation approach aligned with GAMP 5 guidelines. | |
| Coordinate with QA, IT, Production, and vendors for validation activities and system integration. |