Our client, a leading Indian Bio-pharmaceutical company is looking for a Manufacturing IT Admin who will be responsible for:
• Executing the QMS documentation related manufacturing system support function (like CAPA, Incident, Change & Deviation Management process)
• Create operational SOPs, DQ, IQ, OQ, PQ, RQ and Qualification documents
• Experience in facing internal / external regulatory audits.
You will be working with:
Internal Stakeholders – Staff from Engineering and Instrumentation, Quality Assurance and Quality Control, Production, EHS.
External stakeholders – OEM Vendors, Automation consultants, Auditors
• Familiar with manufacturing environment SCADA, HMI, PLC, DCS Process equipment’s, HVAC, BMS, Water System, Utilities System engineering and automation incl. connectivity, communication, configurations, and operations
• Familiar with computerised /non- computerised systems GxP validation and 21CFR operations guidelines.
• Experience in system administration activities of computerised and non-computerised equipment’s in manufacturing area like User access mgmt, Data backup and restoration, Time sync, CSV etc.