Yogesh B. Labhsetwar
Bangalore
Summary
Experienced leader with strong background in guiding teams, managing complex projects, and achieving strategic objectives. Excels in developing efficient processes, ensuring high standards, and aligning efforts with organizational goals. Known for collaborative approach and commitment to excellence.
Overview
29
29
years of professional experience
Work History
Site Head – OSD
Biocon Pharma Limited
02.2019 - Current
- Responsible for site operation for delivering the requirements for Tablets & Capsules from Potent & Non Potent Block with compliance to safety & quality.
- Leading team of around 200 members covering manufacturing, packing, engineering, warehouse & allied departments.
- Plan & execution of Manufacturing & Packing plan for Scale up, Exhibit & Commercial batches.
- To ensure the proper maintenance of Manufacturing premises and equipment.
- Effective utilization of the resources through continuous improvement plan.
- Compliance to Current Good Manufacturing Practices at shop floor & related improvements to meet the current regulatory requirements.
- Maintaining the warehouse inventory as per the budget & focus on utilization of slow-moving inventory.
- Ensuring fast and effective communication with internal and external customers.
- To ensure that all the systems and equipment’s of production are periodically validated, calibrated and automated, wherever required, as per the procedures and requirements.
- To ensure that the products are manufactured and stored according to appropriate documentation in order to maintain the required quality.
- To ensure effective implementation of Quality Management system as per cGMP and regulatory requirement at all levels of Manufacturing.
- Responsible for maintaining the adherence to the organizations Environment, Health and Safety norms.
- Monitoring and control of the resource utilization, yield, rejection.
- To Inspect, investigate & monitor factors which can affect product quality.
- Responsible for the readiness of the product launch from site as per the new product launch calendar.
- Monitoring & control on the Opex & Capex as per per budget.
- Initiation & Coordination for strategic new initiatives like long range plan, projects, facility expansions, de-bottlenecking of capacities, etc.
- Identifying training needs, providing guidance and mentorship, and facilitating skill development of team.
- Biocon is a global biopharmaceutical company with a focus on providing affordable, high-quality medicines to patients worldwide. It is a leading player in generics with a presence in major markets of the world. Biocon aims to improve patient lives by addressing unmet medical needs through its innovative therapies and research. The Company manufactures and markets a range of pharmaceutical formulations as branded generics, as well as generics.
General Manager – Production
Sun Pharmaceutical Industries Ltd
12.2014 - 01.2019
- Responsible for scheduling and execution of Manufacturing & Packing plan for Scale up, Exhibit & Commercial batches.
- Ensure effective utilization of resources through proper Planning & Scheduling of scale up, Exhibit, pre validation batches, validation and commercial batches.
- Responsible for meeting committed month on month market requirement of products on continuous basis.
- Key member of the CD remediation plan as a part of US - FDA requirement.
- Daily monitoring of line scheduling and review of plan vs actual on weekly basis and cumulatively on monthly basis.
- Compliance to Current Good Manufacturing Practices at shop floor to meet the current regulatory requirements.
- Review of current practices and introducing new effective/ efficient/ complaint methods to achieve over all section, plant and organization objective.
- To ensure adherence to the organizations Environment, Health and Safety norms.
- Ensuring fast and effective communication with internal and external customers.
- Ensuring adherence to service level agreements with cross functional team.
- To ensure that all the systems and equipment’s of production are periodically validated, calibrated and Automated, wherever required, as per the procedures and requirements.
- To ensure that the products are manufactured and stored according to appropriate documentation in order to maintain the required quality.
- Implementation of Quality system of Site and quality culture in Production area.
- Review and approval of Master documents, Standard operating procedure, specification of raw materials, packaging material and drug products, validation, qualification protocols and reports.
- To ensure the proper maintenance of Manufacturing premises and equipment.
- Sun Pharma is world’s forth largest specialty generic pharmaceutical company. In India, it becomes number one pharmaceutical company by revenue after acquisition of Ranbaxy laboratories in 2015. The company is known for its research based innovative, cost effective products in market. The Company manufactures and markets a range of pharmaceutical formulations as branded generics, as well as generics across five continents, covering more than 150 nations, with major presence in the United States, India, Europe & emerging market.
Divisional Manager - Production
Abbott Healthcare Pvt Ltd
10.2005 - 12.2014
- Ensure effective utilization of resources through proper Planning & Scheduling of all Manufacturing & Packing Lines.
- To ensure that product are produced and stored according to the appropriate documentation in order to obtain the required quality.
- To ensure smooth internalization of new product through effective coordination with cross functional team.
- To ensure effective implementation of Quality Management system as per cGMP and regulatory requirement at all levels of Manufacturing.
- Monitor progress of various initiatives through weekly SFTI meeting.
- Monitoring and meeting the production plan as per market requirement.
- Monitoring of SAP activities for the PP module.
- Coordination for strategic new initiatives like long range plan, projects, facility expansions.
- To ensure that the appropriate validations are carried out in the plant.
- Key member of Lean Manufacturing team.
- To ensure that the required initial and continuing training of department personnel is carried out and adapted according to need.
- Investigation in case of any process deviation, Noncompliance, market complaints, Product failure, Product recall and out of specification.
- To ensure the maintenance of plant, premises and equipment.
- To Inspect, investigate & monitor factors which can affect product quality.
- To Monitor compliance with the requirements of current Good Manufacturing Practices.
- Co-ordination for installation and qualification of production equipment’s.
- Compliance to specifications and validated processes / methods.
- Certification of the Production Executives for their qualification to specific task or to train further for specific equipment.
- Review of Master Documents, Batch Documents, Standard Operating Procedures(SOP), Production related other documents, etc.
- Compliance to Master documents.
- Making Corrective & Preventive actions for observed Non- conformance.
- To ensure the effective control over the process variables affecting the quality of the product.
- Abbott is among world’s top ten companies in healthcare industry. In India, Abbott Healthcare business division is formed by acquiring Indian Business of Piramal Healthcare in 2010 by Abbott. The company is known for its proven research capabilities for delivering new innovative products in market. The company’s main focus is on delivering quality products to each patient through A Promise for Life.
Production Manager
Dr Reddy’s Laboratories Limited
11.2000 - 10.2005
- Compliance to laid standard of the current Good Manufacturing Practices.
- Co-ordination for Installation and qualification of production equipment’s.
- Meeting the production plan of Tablets / Capsules & Packing as per requirement.
- Training and evaluation of the Production officers for their qualification of specific task.
- Review of Standard Operating Procedures, Master documents of production and batch documents etc.
- Compliance to Master documents.
- To exercise effective control over the process variables affecting the quality of the product.
- To ensure that the production records are evaluated and signed by authorized personnel.
- To ensure that the required initial and continuing training of department personnel is carried out.
- Monitoring and control of the manpower utilization, yield, waste data and Budget.
- To ensure effective implementation of Quality Management system as per cGMP and International regulatory requirement at all stages of Manufacturing.
- Production Planning and scheduling and Inventory Control of Formulation Techops-II.
- Dr. Reddy’s Laboratories is an emerging global pharmaceutical company with proven research capability. The company is focused on creating & delivering innovative and quality products to help people lead healthier lives. The company is expertise in development & manufacture of quality organic intermediates, bulk actives and finished dosage form, which have been critical to success in delivering innovative & affordable life saving medicines to customers world-wide, including Europe & United States.
Production Executive
Cadila Pharmaceuticals Limited
10.1996 - 11.2000
- Cadila Pharmaceuticals Limited is an India based growing pharmaceutical company, which headquarter is at Ahmedabad, with an expertise of more than 5 decades in the Indian healthcare industry. Cadila is known for its cost effective product delivery to market. The company is focused on manufacturing & marketing of the formulation products & active pharmaceuticals ingredients in India as well as globally. Company enjoys a diversified & growing presence in regulated & developing international market.
Education
B.Pharm -
S N Institute of Pharmacy
PusadM.S. - Pharmaceutical Operation & Management
Birla Institute of Technology & Science (BITS)
PilaniPGDBA - Operations
Indira Gandhi National Open University
New DelhiSkills
- Project management
- Facility expansion
- Regulatory Compliance
- Operational Excellence
- Advance Planning Optimizer (APO)
- Electronic Batch Record (EBR)
- Site remediation planning
- Cross-functional team leadership
- New product internalization
- Product mix optimization
- Cost reduction strategies
- ERP system harmonization
- Automation
- ISO certification
- Cost reduction strategies
- ERP system harmonization
- Automation
- Training and development
- CGMP compliance
Languages
Marathi
Hindi
English
Gujarati
Telgu
Banjari
Regulatory Audit Exposure
- USFDA
- MHRA
- TGA
- MCC
- PIC (Romania)
- ANVISA (Brazil)
- MOH – Russia
- Tanzania
- Ghana
- NDA Uganda
- SFDA – Saudi
- WHO
- Nova Nor-disk
- Latvia
- Various customer audit in Cadila Pharmaceuticals / Dr. Reddy’s Labs / Piramal Healthcare Limited / Biocon Pharma Limited
Mailing Address
F 1303, Concorde Manhattan, Neeladri Road, Electronic City, Phase I, Bangalore, Karnataka, 560100
Personal Information
- Date of Birth: 01st July 1975
- Marital Status: Married
Playing Sports, Travelling, Exploring new places
Sports, Nature Walk, Travel, Exploring new places
Timeline
Site Head – OSD
Biocon Pharma Limited
02.2019 - Current
General Manager – Production
Sun Pharmaceutical Industries Ltd
12.2014 - 01.2019
Divisional Manager - Production
Abbott Healthcare Pvt Ltd
10.2005 - 12.2014
Production Manager
Dr Reddy’s Laboratories Limited
11.2000 - 10.2005
Production Executive
Cadila Pharmaceuticals Limited
10.1996 - 11.2000
M.S. - Pharmaceutical Operation & Management
Birla Institute of Technology & Science (BITS)
PGDBA - Operations
Indira Gandhi National Open University
B.Pharm -
S N Institute of Pharmacy