Bharatkumar Agrawal
Langdon,PA
Summary
Proven Leader with excellent client oversight and issue resolution talents. Highly effective overseeing multiple tasks and employees at once. Dedicated to detail-oriented leadership and goal-oriented planning.
Awardee - IFAH 2020-21 “Top 100 Healthcare Leaders” 15+ Years of experience in FDA regulated Industry. Knowledge of Regulatory agency requirements – FDA, Health Canada & EU Successful track record with FDA, MHRA, ISO and Customer audits Expertise with Process validation, Cleaning validation, CQV, Packaging Qualification, Room Qualification, Warehouse Mapping Hands on experience with Environmental monitoring, Managing customer complaints, Dealing with Risk based tools etc.
Overview
13
13
years of professional experience
1
1
Certification
Work History
Senior Consultant / Project Manager
Hyde Engineering & Consulting
05.2020 - Current
- Client - Astrazeneca
- Team Lead and Project Manager for CQV program for MAB Production site Shutdown – Scope included MM$$ investment to improve production plant efficiency by replacing old equipment with state-of-art machinery
- Managing ~4 Hyde employees focusing quality of work and providing technical support
- Developed documentation schedule and tracked execution activities to complete project work
- Project scope included VMP, CQV activities for production equipment – Bioreactors, Chromatography Skids, Purification UF/DF/Buffer/Media Prep Tanks, CIP/SIP Circuit Analysis, Part Washers etc.
- Client - Boehringer Ingelheim
- Managed PPQ & CPV programs for client site for NBEs and Biosimilars
- Led the Tech transfers for MAB Upstream/Downstream/Fill Finish processes working with cross functional teams (R&D, Ops, Supply chain, QC & QA)
- Authored Control strategy, Upstream/ Downstream/ Drug Substance/ Drug Product PPQ protocols and reports, Resin lifetime study protocols and reports, Media fill protocols and reports, Technical assessments, Investigations (RCA) etc.
- Statistical review of data for commercial biopharma products over life cycle
- Establishing control limits, process capability indices, determining Trend signals and remediation plan under CPV program
- Client – Novartis
- Team Lead for site CQV program Gap Assessment and Remediation project
- Global effort involved multiple client sites for CQV program assessment
- Responsible for reviewing and identifying Gaps in Site' CQV program against Global Standards and providing optimized remediation plan to reduce equipment downtime
- Client – Prince Sterilization
- Team Lead and Project Manager for C&Q program of new production site
- Managing ~6 Hyde employees focusing quality of work and providing technical support
- Developed documentation schedule and tracked execution activities to complete project work
- Project scope included VMP, Clean Rooms qualification, Utilities qualification and CQV activities for production equipment – Autoclaves, Depyrogenation Tunnel, Vial packaging line, Sealers etc.
- Client – Goodwin Biotechnology
- Team Lead and Project Manager for CQV program of client site
- Managing ~4 Hyde employees focusing quality of work and providing technical support
- Developed documentation schedule and tracked execution activities to complete project work
- Project scope included VMP, Clean Rooms qualification, Environmental Monitoring program, Media Fill Studies, Quality & Validation program SOPs etc.
Validation Manager
Cambrex (Halo) Pharmaceutical
01.2018 - 05.2020
- Oversee Process and Cleaning Validation operations for site
- Manage ~6 Validation specialists' workload and skills development, provided technical support
- Successfully completed PPQ executions of more than 10 products, including NDAs, ANDA and Tech transfers
- Successfully led PPQ efforts for MM$ product launch with 6 month market exclusivity
- Proficient with JMP software - Data Analysis, Stage 3 - CPV packages
- Packaging Validation & Serialization
Senior Validation Specialist
Halo Pharmaceutical
10.2016 - 01.2018
- SME for Cleaning and Process Validation Program
- Conducts qualification and validation studies for manufacturing processes, equipment, utilities and cleaning validation
- Responsible for the coordination of supportive validation activities (such as laboratory testing, calibration, scale-up and engineering studies) and assurance that the necessary project documentation is complete, accurate and in compliance with cGMP regulations
- Review technical documentation (batch records, SOPs, calibration records, preventive maintenance work orders, protocols, reports) for continuity and accuracy
- Perform gap assessments and remediation as required on legacy qualification and validation packages.
Validation Engineer
Medical Products Laboratories Inc
05.2011 - 09.2016
- Cleaning Validation
- Analyzed product integrity and its behavior regarding respective cleaning agents and procedures. Prepared and executed Cleaning Validation Test Protocols using Swab and Rinse Technique and analyzed critical areas for cleaning.
- Developed complex matrix with major focus on API dosage, solubility and toxicity to leverage cleaning validation of Multi product and dosage manufacturing facility.
- Developed acceptance criteria (MACO) regarding product strength and dose. Used 1/1000th approach for developing acceptance criteria and proving robustness of cleaning procedure.
- Validated cleaning procedures for Hobart mixer, Ribbon Blender, V Blender, Bulk tanks, Tablet press etc.
- Developed Cleaning Validation Monitoring program and New Equipment Cleaning developmental study protocols.
- Determined Dirty Hold Time and Clean Hold Time for Pharmaceutical production Equipment
- Process Validation
- Prepared and executed Process Validation protocols after detailed review of manufacturing instructions.
- Determined process capability index by using statistical data to prove a robust process and validation.
- Determined sampling spots for process validation to cover all dead spot testing in blend.
- Hands on experience with Equipment Qualifications, Packaging line qualifications and Room qualifications
Quality / Equipment Engineer
Medical Products Laboratories
08.2010 - 05.2011
- Handled Investigations related to Manufacturing and Packaging Operations
- Customer Complaint management, Handled CAPA, Change controls and Deviations
- Authored SOPs on Operating, Maintenance and Cleaning Procedure for Equipment/ Instruments
- Managed company's PM and Calibration Program
- Used Lean Sigma Methodology to develop a system to achieve quality products with focus of optimizing the production time by reducing machine down times and wastes.
Quality Assurance Inspector
Nutra-Med Packaging
12.2009 - 08.2010
- Inspection of packaging lines includes visual inspections – labeling, lot number, expiry dates etc., leak test, seal test, tablet count, room and line clearance etc
- Batch record review and Reconciliation
- Reviewed Master Specifications for Labeling materials like Cartons, Labels and Inserts
- Conducted Internal Audits and performed Calibrations and execution of Protocols
Education
Certificate: Validation and Regulatory Affairs in Pharmaceutical Manufacturing -
Stevens Institute of Technology
Hoboken, NJ05.2010
Master of Science - Pharmaceutical Manufacturing G.P
Stevens Institute of Technology
2010
Bachelor of Pharmacy G.P.A -
Gujarat University
Gujarat, India2008
Skills
- Skills - Six Sigma Black Belt, Lean Manufacturing, Root Cause Analysis, Failure Mode and Effective Analysis, Process Validation, Cleaning Validation, Process Capability, Process Monitoring, Tech Transfer, Process Engineering, QbD, Continuous Process Improvement, Statistical Analysis, Control Charts, CPV, Maximum Safe Carryover Calculation, Recovery Study, Swab & Rinse sampling Technique, Visual Inspection Technique, Technical Writing, Regulatory Agency Audits, Client Audits, P & IDs, TOPs, SIA, URS, DQ, IQ, OQ, PQ, Commissioning, Qualification, Validation, Temperature Mapping, Warehouse Mapping
- Software - JMP, MS Office Suite, TrackWise, Document Management Systems, GoTrack, Kneat
- Products - MAB, Upstream process, Downstream process, Solid and Liquid Oral Formulations, Semi Solid Formulations
Accomplishments
Top 100 Healthcare Leaders 2020-21
Affiliations
Vice President of Stevens' chapter of International Society of Pharmaceutical Engineering (ISPE), Member of Stevens Pharmaceutical Research Group Team, Volunteer at BAPS-USA
Timeline
Senior Consultant / Project Manager
Hyde Engineering & Consulting
05.2020 - Current
Validation Manager
Cambrex (Halo) Pharmaceutical
01.2018 - 05.2020
Senior Validation Specialist
Halo Pharmaceutical
10.2016 - 01.2018
Validation Engineer
Medical Products Laboratories Inc
05.2011 - 09.2016
Quality / Equipment Engineer
Medical Products Laboratories
08.2010 - 05.2011
Quality Assurance Inspector
Nutra-Med Packaging
12.2009 - 08.2010
Certificate: Validation and Regulatory Affairs in Pharmaceutical Manufacturing -
Stevens Institute of Technology
Master of Science - Pharmaceutical Manufacturing G.P
Stevens Institute of Technology
Bachelor of Pharmacy G.P.A -
Gujarat University
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