Tushar V. Pagar
Summary
Dedicated manufacturing professional seeking a position to contribute to organizational growth. Known for creativity, smart work, and strong work ethic.
Bachelor of Pharmacy with 17.5 years of experience in production activities, specializing in tablet and capsule formulation. Adept at handling regulatory audits by USFDA, MHRA, and WHO, ensuring compliance with cGMP and WHO guidelines.
Overview
18
18
years of professional experience
1
1
Certification
Work History
Production Section Head and QMS Compliance
Macleods Pharmaceuticals Ltd
01.2013 - Current
- Managed and oversaw the manufacturing processes for OSD products including Granulation, Compression, and Capsule Filling.
- Handling day-to-day production activities, online documentation, and QMS activities.
- Facilitated effective communication and collaboration between PPIC, QA, QC, warehouse, and Engineering departments for streamlined production operations.
- Played a key role in enhancing monthly production output from 70 million to 100 million as part of the team at Macleods Pharmaceuticals Ltd, Daman.
- Process time reduction by removal of inspection stage for uncoated and coated tablets by performing AQL at compression stage for uncoated tablets, and AQL at coating stage for coated tablets.
- Achieved a 5% yield improvement on bi-layer products through upgrading the compression machine, enhancing control of the first layer rejection mechanism to reduce weight variation and minimize OOS results
- Gap assessment study performed for equipment to evaluate the gap assessment in cleaning as well as operation procedure to simplify SOPs by incorporating photographs, flow charts, cleaning cycle tables, identify difficult to clean area of equipment
- Revision of equipment SOPs for categorization of alarm on manufacturing and packing equipment (Impacting and non- impacting) and evaluation for action to be taken for alarms
- Development and validation of effective duct cleaning procedure with minimum usage of purified water at minimum time by using Karcher High pressure cleaner for cleaning of duct of FBD/FBP/Autocoater
Compression and Capsule Area
Emcure Pharmaceuticals Limited
08.2009 - 01.2013
- Part of team for achieving record-breaking production output of 600 million in Emcure Pharmaceuticals, Pune.
- Handling of activities such as compression and capsule filling.
- Handling of shift, online documentation, daily calibration, and daily production activities.
- Coordination with QA, QC, Warehouse and Engineering department for smooth production.
- Coordination with the production manager and packing department for the production plan.
Granulation, Compression and Coating Area
Piramal Healthcare Ltd.
05.2008 - 08.2009
- Handling of activities such as Granulation, compression and coating.
- Responsible for logbook, BMR, Daily calibration and daily production activities.
- Coordination with QA, QC and Engineering department for smooth production.
- Coordination with production Executive for production plan.
Granulation and Compression area
Aurochem Pharmaceuticals Pvt. Ltd.
12.2006 - 05.2008
- Handling of activities such as Granulation, compression and coating.
- Responsible for logbook, BMR, Daily calibration and daily production activities.
Education
Bachelor of Pharmacy -
Pravara Rural College of Pharmacy
Pune04-2006
Skills
- Workforce Development
- Performance Improvement
- Process Improvement
- Problem-Solving
- Effective Communication
- Team Leadership
QMS Documentation & Software skill
- Trackwise- Handling of Deviation (Planned and Unplanned), Preparation of investigation reports,
Initiation of Change control (Permanent and Temporary) and completion of change control
activities.
- Expertise in preparation of Risk Assessment related to process, facility and equipment.
- DMS - Handling of document issuance and SOP preparation.
- PLMS - Overall training activities.
- SAP (HANA S4) & ERP for material management.
Equipment Handling
- Rapid Mixer Granulator: Bectochem / Ganson 600 L
- FBD: Bectochem / Ganson 250 Kg.
- Bin Blender: Ganson 1200/600/300/60 L
- Roll compactor: Chamunda make
- Compression machines- Legacy-6100 (Station: 37/45) , Korsch (Station: 65 and 53) , Sejong HRC, (Station: 49, 51), Cadpress IIA (Station: 37), Cadpress – IV (Station: 45), C-300 Cadpress (Station: 49).
- Auto coater- Ganson 60’’
- AF-90T Capsule filling Machine with powder / pallet and tablet filling attachments.
- Tablet printing machine (Tamprint-60)
Roles And Responsibilities
- Establishes production standards of efficiency, minimum wastage and maximum utilization of resources.
- Establishes quality standards, procedures and monitoring of production area.
- Batches execution timely follow-ups and extensive coordination with all relevant departments.
- Supervise machine maintenance program.
- Documentation control of entire production area.
- Monitoring of trouble-shooting and remedial action for large scale production batches.
- Preparation and review of equipment and system SOP’s.
- Efficient team handling and motivating the team for continuous improvements.
- Responsible for continues monitoring of Quality Products.
- Trained on various regulatory audits and system requirement.
- Online SAP and ERP entries of the batch transaction.
- Co-ordination & communication with internal & external customers.
- Involved in the preparation, execution and review of Protocols, Reports.
- Preparing for MIS reports including presentations, monthly reports.
Personal Information
- Native Place: Nashik (MH)
- Date of Birth: 06/10/85
- Marital Status: Married
Languages
Marathi
First Language
English
Upper Intermediate (B2)
B2
Hindi
Upper Intermediate (B2)
B2
Certification
- FDA approved certification for Tablet and Capsule Manufacturing from Administration of DNH, Daman and Diu (U.T.)
Timeline
Production Section Head and QMS Compliance
Macleods Pharmaceuticals Ltd
01.2013 - Current
Compression and Capsule Area
Emcure Pharmaceuticals Limited
08.2009 - 01.2013
Granulation, Compression and Coating Area
Piramal Healthcare Ltd.
05.2008 - 08.2009
Granulation and Compression area
Aurochem Pharmaceuticals Pvt. Ltd.
12.2006 - 05.2008
Bachelor of Pharmacy -
Pravara Rural College of Pharmacy
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