Instrumentation Manager

Carryout / Review calibration (instruments: pressure, temperature, flow, UV, TOC, pH, conductivity, VOC etc.

Carryout / Review Preventive Maintenance of PSVB, Control Panels etc.

Planning & Execution of different types of maintenance & trouble shooting of instruments / control systems (PLC /DCS / MES) and its accessories in co-ordination with OEM /Service providers.

Review / execution of CSV of control systems /instrument qualification documents as per procedures & guidelines. Handling of online qualification software (Val Genesis etc.)

Ensure all the audit findings are closed within the stipulated time.

Planning and procurement of spares and consumables.

Review of documents for data entry and recoding related to Quality (Deviation reports, change controls, risk assessment etc.) and EHS management systems (work permits) and QMS (change management, related activities in digital platform like (track wise, DMS etc.)

To ensure smooth running of audits (internal and external) related to Quality and EHS management systems.

Reporting of non-conformities, adherence, initiation and implementation of the corrective/preventive actions as suggested by Quality Assurance.

To ensure all equipment's (control systems) and instruments are operated and maintained as per manufacturer's recommendation.

Co-ordination with contract services providers for the equipment's and instruments AMC / Break down service.

Co-ordination in inventory management in digital platform like (ERP, SAP etc...)

Planning, Coordination & Execution of CSV activities and equipment Qualification / Requalification.

Creation of standard operating procedures in Procedure module (FileNet software, DMS etc..)

Knowledge in handling, trouble shooting of PLC / DCS / MES related hardware & software.

Knowledge in handling of clean room applications (EMS, BMS etc..), equipment's & concepts.

Knowledge in handing of water system application (UV, TOC etc...) & equipment's related to PWP & WFI.

Project management which includes Planning, Execution, Monitoring & Closure.

Equipment Qualification, Preventive Maintenance, Building Maintenance and Calibration plans and execution of the plan as per cGMP regulations.

To ensure all the legal requirements are met and initiate suitable action in the event of any discrepancy is noted. Interact with regulatory authorities with matters concerning the legal requirements. Department of Weights and Measures)

Costing and Budgeting for Engineering and Asset Maintenance and monitor the expenditure to control the expenditure as per Budgets.