Rahul Dhume
Goa
Summary
Pharma Mechanical Engineer with 10+ years experience in Mechanical
Maintenance, QMS, HVAC, Equipment Validations and Qualifications.
Knowledge on Regulatory Guidelines such as ISO 14644, 21 CFR Part 11,
GAMP 5
Overview
11
11
years of professional experience
Work History
Assistant Manager
Cipla Ltd
Goa
05.2020 - Current
- Carrying out Preventive maintenance and breakdown
maintenance of production equipments such as FBE, Wurster
coater, Tablet Coating Machine, Compression machine, Blender,
Sifter.
• Raising purchase Requsition and co-ordination with Vendors/OEM
for maintaining critical spare parts
• Carrying out HVAC and RLAF validations as per annual schedule
and documenting it.
• Co-ordination with external vendors and cross functional team
for completion of maintenance/modifications as per Job orders in SAP
• Drafting Floor layouts and P&IDs in AutoCad 2D.
• Handling QMS documents such as Change Requests, CAPA,
Deviations and FMECA.
• Preparation and Execution of HVAC/Area qualifications.
• Carrying out Temperature and RH distribution study for newly
modified area and Routine seasonal studies
• Ensuring readiness of documents for regulatory audits and Audit
Compliance.
• Execution of in house Projects
Projects Handled:
1. Area Modification and Re-location of HVAC system for specific
RH Requirment for New blender installation along with HVAC
qualification - Installation, Commisioning and Qualification of new RLAF in
Stores Dispensing area.
Senior Officer
Glenmark Pharma Pvt. Ltd
Goa
05.2019 - 03.2020
- Handling shift operations of HVAC systems on service floor.
• Co-ordination with service floor technicians for maintaining
Temperature, RH and differential Pressure of areas during shifts
• Handling Preventive maintenance and filter cleaning activity of
AHUs.
Officer
Mabpharm pvt. Ltd (subsidiary of Cipla Ltd)
Goa
05.2015 - 05.2019
- Carrying out Preventive and Breakdown maintenance of
production, water system, quality control and stores equipments
such as Autoclave, Laminar Air Flow units, Manufacturing tanks,
Filling and sealing machines, Tunnel sterilizer, Lyophilizer.
• Carrying out AHU and LAF/RLAF Validations with help of external
vendor along with completion of Validation Reports.
• Preparing annual Preventive maintenance and HVAC validation
schedules.
• Handling of shift operations on service floor which involved
BMS operation and writing alarm summary reports, Preventive
maintenance and filter cleaning activity of AHUs.
• Drafting Floor layouts and P&IDs in AutoCad 2D.
Education
B.E Mechanical -
Finolex Academy of Management And Technology
Mumbai UniversitySkills
- Equipment maintenance
- HVAC validation/Qualification
- Preventive maintenance
- AutoCAD drafting
- Quality management systems
- Regulatory compliance
- Project coordination
- Computer System Validation
Timeline
Assistant Manager
Cipla Ltd
05.2020 - Current
Senior Officer
Glenmark Pharma Pvt. Ltd
05.2019 - 03.2020
Officer
Mabpharm pvt. Ltd (subsidiary of Cipla Ltd)
05.2015 - 05.2019
B.E Mechanical -
Finolex Academy of Management And Technology