Job Description

Required Skills: • Resource with 2 -8 years of Relevant experience in Computerized System Validations of Enterprise applications (SAP/LIMS/TrackWise etc.), Equipment and Instrument validations (Manufacturing, Packaging, QC equipment/instruments and Serialization etc.). • Experience in Preparation and Execution of CSV deliverables (IQ, OQ and PQ). • Exposure in Assessment, Review and Preparation of 21 CFR part 11, EU annex 11 Compliance Assessment/Report. • Review of User, Error, Audit Trail records. • Skilled in Risk Assessment for Equipment/Instrument Operations. • Experience in Handling of QMS events (Change control, Deviation, RCI and CAPA). • Experience in Handling of end to end project CSV activities (is an added advantage). Technical Skills required: • Knowledge on handling of ValGenesis Application. • Hands on instrumentation, semi automation or automation • Worked on different layers of automation systems • Knowledge of IT- Operations, data and security management, backup & restore activities, • Exposure to maintenance, troubleshooting of GxP systems, • Understanding of technical & procedural risk assessment and actions. Soft skills (behavioral) required: Self-learner, Team player, Good Communication and Coordination with CFT etc. Any other specification / Requirement: • B. Tech, B.E. B.Sc. – Instrumentation /Electronics/ IT /B. Sc. (Computer Science) having knowledge of SAP, TrackWise, MES, BMS, EMS etc. • B. Pharmacy with exposure in regulation, analytical instrumentation, exposure to production activities along with exposure to latest software LIMS, HPLC etc. Experience Range: 2 to 8 years in Engineering, Consultancy, IT, CSV in Pharma domain