Nandkumar Mali
Bangalore
Summary
Dynamic Senior Team Leader at Mylan Lab. Ltd. with expertise in quality management and regulatory compliance. Proven track record in optimizing production processes and enhancing team performance. Skilled in equipment validation and cross-department coordination, driving continuous improvement initiatives to achieve business objectives and ensure zero accidents on the production floor.
Overview
28
28
years of professional experience
1
1
Certification
Work History
Senior Team Leader
Mylan Lab. Ltd.
Bangalore
04.2014 - Current
- Company Overview: 100% EOU facility.
- Overall maintenance of the QMS for the production of liquid, lyophilized products, IV bags, and PFS products.
- Responsible for maintaining the company's overall production QMS status up to date, from logging to closure of records.
- Tracking the daily QMS activities status and delegation of activities to concerned persons to achieve target closure dates to fulfill the batch release plan.
- Co-ordinator for vendor investigations, follow-ups raised as part of PMSI incidents, as well as inputs required for investigation from R&D and Tech Transfer team.
- Responsible for the clearance of OOT/OOS, OOL investigation records from the site CFT team, as well as the Global team.
- Familiar with software like TrackWise, D2-Documentum, and MES-Manufacturing Execution System.
- Reviewer for records in D2-Documentum, BMR, BPR, MFR, and validation protocols.
- I worked on the production shop floor as a shift leader and was responsible for the following activities.
- Planning and scheduling production activities, and execution of the same, with effective utilization of existing resources.
- Consistently observe improvement in productivity and process troubleshooting.
- Ensuring optimum utilization of the resources, such as machines, materials, and manpower, to achieve targeted output.
- Ensure 100% statutory compliance, and achieve zero accidents at the production shop floor.
- Achieve the company's business objectives on matters relating to manufacturing processes, consistent with the company’s quality policy.
- Conducting training related to new SOPs, CAPA, deviations, and the outcome of QMS as per company policy.
Asst. Manager- Production
Microlabs Ltd.
Bangalore
12.2007 - 03.2014
- Effective planning for optimum utilization of manpower and machines to achieve targeted output.
- Coordinator for other departments, like QA, QC, and Engg. get work done within the stipulated time.
- Exposure to the handling of the imported MACOFAR vial filling line.
- Monitoring the operation and validation of equipment like W600, T600, and Micro9.
- Preparation and review of BMR, BPR, MFR, and validation protocols.
- Experience in the validation of machines or equipment related to the manufacturing process.
- Extensive experience in conducting successful media fill trials to assure the area and equipment for aseptic activities.
- Providing suggestions related to cost-saving and system improvements.
- Identifying areas of quality failure and taking steps to rectify the same.
- Train subordinates to cater to recent GMP aspects.
- Responsible for raising the URS and CERs for capital budgetary items and equipment.
- Address employee concerns and complaints in a professional manner.
- Ensure safety measures and procedures are followed to reduce unexpected incidents and hazards.
Production Officer – Dry Powder Injectable Section
Okasa Pharma Pvt. Ltd.
Satara
02.1999 - 11.2007
- Workout, planning, and implementation of shift schedules to acquire targeted output as per monthly production plans.
- Productive utilization of man, machine, and material as per cGMP.
- Identification and rectification of various shop floor problems during processing and packing.
- Evaluation of in-process checks.
- Trainer for new operators working in the production area.
- Actively involved and responsible member of the validation team for the autoclave, dry heat sterilizer, AHU/LAF, and water system.
- Involved in purchasing, inspection, commissioning, and installation of equipment/instruments.
- Involved in the preparation of SOPs, daily records, flow charts, and documents related to inspections.
- Actively involved in the manufacturing and establishment of new products for the local and export markets after research and development trials.
- Efficiently handled equipment like Auto D.M. Plant, Multicolumn Distillation Plant, Pure Steam Generator, Autoclave, Dry Heat Sterilizer, and Automatic Powder Filling & Sealing Machine (AHPF-120).
- Worked in the tablet dry/wet granulations section, compression, and film coating section.
Production Officer
Blue Cross Laboratories Ltd.
Nashik
06.1998 - 02.1999
- Worked in granulation section and handled saizoner mixer, steam kettles, Steam heated FBD, octagonal blenders, double rotary compression machines
- Involved in dispensing of material like β-lactams, cephalosporins & general category drugs as well as coating solvents
- Involved in changeover of compression machines
- Involved in cleaning validation of manufacturing equipments
Production Supervisor
Magnachem Pharmaceutical Pvt. Ltd.
Satara
05.1997 - 06.1998
- Handling of dry, wet granulation, and non-aqueous manufacturing.
- Handled moisture-sensitive products.
- Efficiently handled compression and film coating sections.
Education
Bachelor of Pharmacy -
Govt. college of Pharmacy
Karad, Maharashtra, India01.1996
Higher Secondary Certificate -
Maharashtra State Board
Kolhapur, Maharashtra, India01.1992
Secondary School Certificate -
Maharashtra State Board
Pune, Maharashtra, India01.1990
Skills
- Quality management
- Regulatory compliance
- Production planning
- Process improvement
- Equipment validation
- Document management
- Cross-department coordination
- Team leadership
- Employee training
- Time management
Accomplishments
- Effective Team Leadership
- Implemented CAPA initiatives reducing deviations by 50%
- Developed QMS training programs, improving compliance awareness across teams
Personal Information
- Date of Birth: 07/01/74
- Marital Status: Married
Certification
- Approved by FDA Pune as Competent Technical staff in following dosage form.
1. Tablet Section
2. Dry Powder Injectable
Languages
Marathi
First Language
English
Upper Intermediate (B2)
B2
Hindi
Advanced (C1)
C1
KANADDA
Beginner
A1
References
References available upon request.
Timeline
Senior Team Leader
Mylan Lab. Ltd.
04.2014 - Current
Asst. Manager- Production
Microlabs Ltd.
12.2007 - 03.2014
Production Officer – Dry Powder Injectable Section
Okasa Pharma Pvt. Ltd.
02.1999 - 11.2007
Production Officer
Blue Cross Laboratories Ltd.
06.1998 - 02.1999
Production Supervisor
Magnachem Pharmaceutical Pvt. Ltd.
05.1997 - 06.1998
Bachelor of Pharmacy -
Govt. college of Pharmacy
Higher Secondary Certificate -
Maharashtra State Board
Secondary School Certificate -
Maharashtra State Board
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