Job
Description
Role Summary :
1. To handle independently the preventive maintenance, breakdown maintenance, calibration & qualification of lab related equipments / instruments. AMC maintenance of critical equipments.
2. Timely maintenance & rectification of lab equipments like HVAC, chiller, autoclave, area qualification, pressure balancing, incubator, stability chamber, weighing balance, vacuum oven, muffle furnace, humidifier, dispencing booth, diaphgram vacuum pump, water ring vaccum pump, hot air oven, biosafety cabinet, door interlock system, air sampler, fogger, VFD programming and error rectification, 21CFR monitoring device/BMS, filter cleaning booth, clean room equipments, scrubber system, fumehood, pressure instruments testing & certification, lifts, hand pallets maintenance.
3. Should have knowledge on quality management system, GDP, di system, qualification of clean rooms & execution, equipment IQ, OQ & PQ documentation, temperature mapping qualification.
4. Should have knowledge on calibration & to coordinate with external vendor for calibration, temperature mapping, clean room qualification, area modification, breakdown maintenance, AMC pm, equipment upgradation.
5. Inventory management, SAP knowledge for pm activity, stock, breakdown activity, prn creation, notification creation, service entry, QMS compliance.
6. Should work in shifts if required. Should support lab activities during crisis situations.
7. Should have knowledge on EHS & safety compliance, work permit system, FAS system, fire hydrant system, waste management system.
8. Should have knowledge on cad drawing for HVAC facility and layout modification, AC refrigeration & maintenance.
9. Should have knowledge on projects, new modification BOQ, URS preparation & execution and timely project completion.
10. Should be a good team member to indulge with the team. Should execute & update logsheets, checklists online truthfully, adherence to SOPs, CGMP, GLP requirements.
11. Should have knowledge about SOP, IOP, OCP, EOP as per QMS requirement. revision & implementing new SOPs, online QMS.
12. Should be able to face audits from internal & external agency for related works. Completing audit observations within timelines and CAPA implementation.
Key Responsibilities
1. Preventive maintenance, breakdown maintenance of lab equipments & utilities-HVAC, AC, chiller.
2. Clean room qualification, temperature mapping, equipment qualification.
3. Calibration of instruments, raw data & traceability certificate compilation.
4. HVAC operation, pressure balancing, humidity, temperature maintenance & overall maintenance.
5. Critical Stock Maintenance & Utilization, Timely Procurement.
6. Modification of Lab Areas & Lab Facility as per New Requirement, Asset Management.
7. QMS compliance, GLP, GDP, cGMP & online DMS in TRACKWISE & SAP SuccessFactors.
8. EHS & safety compliance, waste management.
9. Commercial activities like PRN creation, service invoice accounting, PRN follow-up with commercial team, follow-up of procured items still qualification completion and supporting user department for project completion.
10. Upgrading aged & critical equipments to increase the lifespan and to reduce downtime. Planning replacement of critical spares & consumables.
11.Handling AMC of equipments for PM, Validation, Calibration, Bills Accounting, timely renewal of AMC.