GAJANAN PATIL
AHMEDABAD
Summary
Injectable Manufacturing Professional with 21 years of experience in plant operations, production, and quality management systems (QMS). Proven expertise in process enhancement and PPMC, with a strong track record working within regulatory markets such as USFDA, MHRA, and EMA. Recognized for analytical thinking and goal-oriented leadership skills that drive project development from conception to execution. Collaborates effectively within teams to foster innovation and growth in processes and personnel.
Overview
21
21
years of professional experience
1
1
Certification
Work History
AGM
INTAS PHARMACEUTICALS LTD
Ahmedabad
07.2009 - Current
- Working on numerous cross-functional teams as designated by the VP of manufacturing for special projects (Ongoing project of isolator & filling machine)
- Maintaining a culture of procedural effectiveness, root-cause analysis investigations and corrective actions
- Managing the commissioning & qualification of one of the expansion line
- Responsible for entire manufacturing activities of Liquid Injectable & Lyophilized vials (Oncology) plant, commissioning & qualification of new Onco expansion line
- Handling a team of 135 persons & 03 injectable lines
- Monitor the implementation of monthly/ short-term/ long-term production plan for respective lines based on production plan
- Provide inputs for preparation of MIS reports; Review and approve batch manufacturing records
- Participate in audit processes with plant production and cross-functional teams for relevant audits
- Training and Planning of work force and its proper utilization in all working shifts
- Maintenance of critically controlled area and working system for quality production with the help of suitable documentation
- SOP, on the job training of new entrants as per laid down standards
- Execution of Process / Equipment validation, system and area qualification along with QA and preparation, review, authorization and maintenance of SOPs, Daily documents
- Indenting of items/accessories & others as required
- Ensure the availability of material on time
- Monthly QRM & streamline the production QMS elements in state of control to complete in stipulated timeframe
- Maintenance of facility & equipment by collaborating with engineering team to meet production schedule, regulatory expectations & facilitate smooth & safe operations
- Introduction of new product molecule in facility with its challenges & to mitigate for achieving desired organizational goal
- Monitoring of operation activities in EBMR, SAP and WDMS
- Involved in CSV for operating system SCADA as per GAMP5 & 21CFR11
Production Executive
Cadila Pharma
Ahmedabad
10.2007 - 07.2009
- Responsible for Cephalosporin Dry Powder injectable filling & packing operations
- Active team member in a productivity improvement project (By national productivity council) of dry powder filling & packing line
Production Executive
Nicholas Piramal
Pithampur
12.2004 - 10.2007
- Manufacturing & Filling operations of small volume injectable (Vial & ophthalmic FFS)
Production Chemist
Samrudh Pharma
Boisar
08.2003 - 12.2004
- Small volume injectable vial & ampoule
Education
B. Pharmacy -
North Maharashtra University
Jalgaon, Maharashtra01.2003
Skills
- Effective Troubleshooting Skills
- Project Execution Management
- Workplace Safety Knowledge
- Budget Optimization
- Effective Systems Integration
- Operational Enhancements
- Effective Communication
- Effective Leadership
- Efficient Manufacturing Practices
- Quality Management System
- Electronic Batch Manufacturing Record
- CSV
- USFDA Compliance Expertise
- EMA
- Good Manufacturing Practices
- SAP Proficiency
- Facility Operations
- Production Workflow Management
- Quality Management
- Validation
- Audit & compliance
- CGMP
- Plant Commissioning Expertise
- Training & Development
- Excellent communication
- Effective Project Management
- Analytical and critical thinking
- Operational Planning
Personal Information
- Date of Birth: 09/30/80
- Gender: Male
Certification
- Critical Thinking for Better Judgment
and Decision-Making : LINKEDIN Credential ID 7225afdee435d4feb52313538bc3f662e5b88f9d0b5ce17a524adf0c19b24abb - Lean Six Sigma Yellow Belt : UDEMY ude.my/UC -48a0c670-5078-4f00-93ea-38a8adc3d047
- Computerized system validation : UDEMY https://www.udemy.com/certificate/UC-7e3f4aa0-8b06-462c-9a16-7a39dbc381d3/
- Business analysis basics: SIMPLILEARN https://simpli.app.link/PZnIVLT6XCb
- Foundations of Project Management : COURSERA https://www.coursera.org/account/accomplishments/certificate/XBXP7XBWCZM6
- Operations and supply chain management : UDEMY UC-2fb220a5-afd3-4e80-9a00-2fa82ada60fc
Timeline
AGM
INTAS PHARMACEUTICALS LTD
07.2009 - Current
Production Executive
Cadila Pharma
10.2007 - 07.2009
Production Executive
Nicholas Piramal
12.2004 - 10.2007
Production Chemist
Samrudh Pharma
08.2003 - 12.2004
- Critical Thinking for Better Judgment
and Decision-Making : LINKEDIN Credential ID 7225afdee435d4feb52313538bc3f662e5b88f9d0b5ce17a524adf0c19b24abb - Lean Six Sigma Yellow Belt : UDEMY ude.my/UC -48a0c670-5078-4f00-93ea-38a8adc3d047
- Computerized system validation : UDEMY https://www.udemy.com/certificate/UC-7e3f4aa0-8b06-462c-9a16-7a39dbc381d3/
- Business analysis basics: SIMPLILEARN https://simpli.app.link/PZnIVLT6XCb
- Foundations of Project Management : COURSERA https://www.coursera.org/account/accomplishments/certificate/XBXP7XBWCZM6
- Operations and supply chain management : UDEMY UC-2fb220a5-afd3-4e80-9a00-2fa82ada60fc
B. Pharmacy -
North Maharashtra University
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