Snehal Patel
Ahmedabad
Summary
A dedicated professional with 11 years of production, compliance and regulatory science experience from prestigious organizations engaged in Biotechnological research and production field. Accomplished with in-depth experience consistently rising through ranks. Well-versed in manufacturing and cGMP compliance of production facility, Design and Management of Bio-pharmaceutical Manufacturing. Forward-thinking team leader skilled at Production, Regulatory submission, Process Validation, Process Quality Assurance, Cleaning Validation, Risk Analysis (for process & equipment), Equipment Qualification, cGMP Documentation, Equipment Validation. Hardworking individual focused on continuous operational improvement.
Overview
11
11
years of professional experience
Work History
Assistant Manager
Intas Pharmaceutical (Biological Unit)
02.2018 - Current
- Regulatory Affairs:
- CMC documentation package preparation for regulatory submission includes initial submission to Health Authorities and query response to Health Authorities.
- eCTD submission through PharmaReady
- Providing documents for tender submission to BD team.
- Change control assessment and tracking for variation,
- Renewal, Variation submission and life cycle management of drug.
- Drug substance Manufacturing:
- Supervised day-to-day operations to meet performance and quality expectations
- GMP audit from Health agency: FDA, EMA, Health Canada, TGA, ANVISA, CDSCO.
- Implemented EBMR for batch record and planned PPQ batches and prepared reports as per health agency's requirement.
- Worked on preparation and execution of equipment qualification and cleaning validation protocol-report, change control management and deviation investigation.
- Reviewed process part of dossier and responded query of different regulatory agencies.
- Process Handling through Akta Process and Akta Pilot.
Senior Executive
Biocon Biologics
01.2015 - 01.2018
- Managed production target of Insulin and Insulin Glargine as per market requirement.
- Done troubleshooting as and when required and minimized process hold, maintained compliance during process, verified process data and analyzed data for improvement of process.
- Planned and executed validation batches, qualification and requalification of equipment.
- Prepared cleaning validation protocol and report, deviation and change control initiation and approval.
- Handled process through Preparative HPLC System (Novasep Prochrom LC800.700), Crystallization, Centrifugation, Freeze Dryer (Telstar).
- Used Lean Manufacturing concept to increase production (6S and OEE implementation at site).
- Conducted internal audits and GAP analysis of system.
Senior Executive
Reliance Life Sciences
12.2012 - 12.2014
- Purified Monoclonal antibody and microbial proteins through Downstream process.
- Control System Used: 8.4.1 Delta V, DCS and HMI.
- Product operated in downstream process: Erythropoietin, Mabs (Adalimumab, Abciximab, Rituximab, Cetuximab, Infliximab, Trastuzumab, Bevacizumab), tPA, GCSF.
- Protein Characterized through technique: SDS PAGE, IEF
Education
PG Diploma - International Business Management
Ahmedabad Management Association
Ahmedabad01.2023
Master of Technology - Biotechnology
Pad.Dr.D.Y.Patil University
Navi Mumbia07.2012
Bachelor of Engineering - Biotechnology
VTU University
Davangere06.2009
Skills
- Regulatory submission
- Purification of Therapeutic protein
- Validation and Qualification of system
- QMS Documentation
Timeline
Assistant Manager
Intas Pharmaceutical (Biological Unit)
02.2018 - Current
Senior Executive
Biocon Biologics
01.2015 - 01.2018
Senior Executive
Reliance Life Sciences
12.2012 - 12.2014
PG Diploma - International Business Management
Ahmedabad Management Association
Master of Technology - Biotechnology
Pad.Dr.D.Y.Patil University
Bachelor of Engineering - Biotechnology
VTU University
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