Listning Music, Playing Cricket
NIRAJ PAWAR
Formulation & Process Development
Mumbai,Maharashtra
Summary
Seeking Continuous Professional Development Opportunities to further Develop & Expertise in Pharmaceutical Product Trouble Shooting by analytical problem-solving approach and attention to its detail.
Overview
2
2
Languages
2
2
Certifications
7
7
years of post-secondary education
11
11
years of professional experience
Work History
Deputy Manager
Cipla Ltd
Mumbai, Maharashtra
10.2017 - Current
- Working on Solid Oral Dosage Form for New Product Development, Process Optimization and Technology Transfer of Product.
- Handling of Scale Up, Exhibit and Commercial Product launches Activities for Regulated Market.
- Handling of Documentation like BMR, BPR, Study Protocols, Study Reports, QBD Stage Documents, Comparative Summary Reports, Statistical Evaluation and Change Controls.
- Participation in QBD stage IV and Gap Analysis.
- Participating in Design of Experiment and PAT studies for New product.
- Evaluation and Finalization of Batch Size & Scalability Calculations.
- Process Improvement for Cost Reduction and to Increase Production Output.
- Handling of Product related OOT, OOS and Root cause Investigation.
- Handling of Trouble shooting activities for New and Existing Products.
- Supporting Plant / CMO Team for Product Transfer activities.
- Alternate Vendor Evaluation for Excipient and Equipments.
- Evaluation of New Technology & Equipment based on the complexity of Process & Product.
- Supporting Equipment Validation and Cleaning Validation Team for New Equipment and New product.
- Supporting Quality Assurance Team for Market Complaint Regulatory Team in Deficiency Response.
- Supporting Site team during Regulatory Inspection and Audit.
Senior Executive
SUN Pharmaceuticals Ltd
Vadodara, Gujrat
07.2015 - 09.2017
- Handling of Product Scale up, Exhibit, Validation and Launch Activities.
- Understanding and Evaluating the Risk associated with Process and Product to Design Controls to Mitigate Product Risk.
- Worked on Soft Gelatin Capsules Technology.
- Support for Regulatory Filling of New products.
- Handling of Scale up and Post Approval Changes (SUPAC) & Variation Filling.
- Support Site Team for Life Cycle Management of Product.
- Evaluation of Prospective Products for Continuous Manufacturing Process for Commercial level.
- Cost Reduction Studies on Existing Product.
- Reviewed Product Performance and Worked with Leadership to Improve Processes, Procedures and Practices.
- Resolved Issues and Recommended Actions based on Production and Compliance Reports.
Executive
Mylan Laboratories Ltd
Aurangabad, Maharashtra
01.2013 - 06.2015
- Participation in Execution of Scale Up, Exhibit, Hold Time, Validation and Launch Batches.
- Preparation and Review of Documents like BMR, Study Protocols, Study Reports, FMEA Documents, Flow Chart, Comparative Summary Reports, Statistical Evaluation.
- Participation in Trials for Product and Process Improvement.
- Participation in Trouble Shooting Exercise for Existing Commercial Product.
- Worked on software like SAP, Track wise (Change Control, Deviation, Incidence) and Minitab (Process capability Evaluation).
- Handling of Root Cause Investigation.
Research Chemist
Unijules Life Sciences Pvt Ltd
Nagpur, Maharashtra
01.2011 - 01.2013
- Product Development for Solid, Liquid and Semisolid Dosage Forms.
- Planned and Conducted Research Experiments.
- Literature Search and collection of Scientific Information
- Preparation of Manufacturing Guidelines, Scale Up protocols and Reports.
- Transfer of New product to Site.
- Pilot, Scale Up and Exhibit Batches Execution
- Evaluation Lab Findings to Make Interpretations and Write Conclusion Reports.
- Cost reduction by Process Modification and Selection of different Raw Materials.
- Stability and Packing Configuration Studies
Project Trainee
Zydus Cadila Ltd
Ahmedabad, Gujrat
08.2009 - 07.2010
- Assisted in Assembling Product Documentation for New Product.
- Assisted Batch Execution to Build Understanding of Processes, Techniques and Industry.
- Worked on Pharmaceutical Quality System and Risk Assessment Implementation Approach on Existing Products.
Education
Master of Pharmacy - Pharmaceutics
RSTM
Nagpur University 08.2008 - 10.2010
Master of Business Administration - Human Resources Development And Marketing
Punjab Technical University
Jalandhar 07.2011 - 11.2013
Bachelor of Pharmacy - Pharmacy
RSTM
Nagpur University 08.2005 - 06.2008
Skills
Process Development
Cost Analysis and Savings
Trouble Shooting
Documentation Skill
Equipment Understanding
Planning & Execution
Certification
Certification on “Patenting system in India” at National Institute of Intellectual Property Management Nagpur
Interests
Timeline
Deputy Manager
Cipla Ltd
10.2017 - Current
Pharmaceutical Sciences and Technology from NIPTE National Institute for Pharmaceutical Technology & Education USA
07-2017
Senior Executive
SUN Pharmaceuticals Ltd
07.2015 - 09.2017
Executive
Mylan Laboratories Ltd
01.2013 - 06.2015
Master of Business Administration - Human Resources Development And Marketing
Punjab Technical University
07.2011 - 11.2013
Research Chemist
Unijules Life Sciences Pvt Ltd
01.2011 - 01.2013
Certification on “Patenting system in India” at National Institute of Intellectual Property Management Nagpur
11-2009
Project Trainee
Zydus Cadila Ltd
08.2009 - 07.2010
Master of Pharmacy - Pharmaceutics
RSTM
08.2008 - 10.2010
Bachelor of Pharmacy - Pharmacy
RSTM
08.2005 - 06.2008