Resume - Milan Prajapati

MILAN
PRAJAPATI

QUALITY EXPERT

PROJECTS
DATA INTEGRITY ASSESSMENT IN QC BIOASSAY LAB - DMAIC tool
WAREHOUSE COMPLIANCE & MANAGEMENT SYSTEM - Event tree & fault tree analysis
BMR review improvement and IPQA monitoring System - Kaizen & Kanban Tool
BLA SUBMISSION FOR GCSF & PEG-GCSF PRODUCTS -Gantt chart & Kanban Board
E-BMR IMPLEMENTATION IN MANUFACTURING PLANT - DMAIC framework
SCALE UP PROJECT IN NEW MANUFACTURING PLANT - DMAIC framework
PERFUSION PROCESS DEVELOPMENT - Poka Yoke, FMEA & DOE
SCALE UP OF ROLLER BOTTLE PROCESS FOR PRODUCT EPO - DMAIC framework

SOFTWARE EXPOSURE
MS OFFICE
TRACKWISE
SAP ERP
EBMR
DMS
MES
MFCS
UNICORN

PROFESSIONAL SKILLS
Leadership
Time Management
Problem Solving
Team Work
Decision Making
Ethical Conduct
Learning

PROFESSION TRAINING
LEAD AUDITOR / ISO 90001: 2015 LA Learning course from UDEMY
DATA INTEGRITY IN PHARMACEUTICALS Learning course from UDEMY
TECHNICAL WRITING at AMA (Ahmedabad Management Academy)
Dissertation project work on Title: “Isolation and identification of bacteria from clinical specimens like urine, sputum, etc...) under HOD, Biotech, Gujarat university on 2009

REFERENCES
Mr. Bhushan Borase
AGM / Manufacturing / Intas Pharmaceuticals Limited 91 8511110603
Mr. Harshit Shah
Associate Director / MSAT / Dr. Reddy Laboratories Ltd 91 97277 53588
Mr. Prakash Hirpara
DGM / Manufacturing / Reliance Life Science Ltd 91 9033117176

About

As a Certified ISO 9001:2015 QMS auditor, I want to grow my carrier in auditing, Data integrity Expert & Quality trainer.
Started my carrier as manufacturing in microbial & mammalian biologics products. Currently working in DS QA section in Biocon biologics ltd. Total 14+ yr experience having 5 yr in manufacturing and 9 yr experience in Quality department.

Experience

Deputy Manager - Quality (DS) , Biocon Biologics Ltd

2020 — Present

Master / Executed Batch Record (MFR/ BMR/BPR) Review.

Tracking & Review Batch Release documents.

Risk Assessment Review, Protocol / Report / Technical document/ SOP Review.

IPQA dashboard set up & monitoring.

ALCOA+++ (DI) compliance monitoring.

Process recipe management.

Review / Approve investigation / Deviation / CAPA / OOS / OOT etc…

Audit readiness & Compliance. Review / Analysis process & system Gaps.

CPV trend evaluation & APQR (Annual product quality Report) Review.

Review / Monitor Process Validation (PV), CV (Cleaning validation), Technology Transfer (TTD) & Other Validations.

cGMP (Good Manufacturing Practices) compliance review & monitor on shop Floor. Review & Monitor Warehouse compliance.

Work with Mammalian Products: Trastuzumab, Bevacizumab, Itolizumab, Pertuzumab, Secukinumab.

Proficient in various software: e-BMR / MES, DMS, SAP EPR, Track-wise, Process Module, Minitab & MS Office.

Assistant manager - Quality (IPQA), Intas Pharmaceuticals Ltd

2015 — 2020

Primary Responsibilities:
Review and approve QMS documents and collaborate with Cross-Functional Teams.
Play a key role in validation, scale-up, gap analysis, and event / deviation investigations.
Create Quarterly and Yearly QMR presentations for management.
Lead QA efforts for the E-BMR project. Vendor Auditor, Internal auditor
Manage large-scale production quality compliance 0f oversee three manufacturing suites.
Authorize Batch Release and manage Audit Query Responses.
Provide critical support for inspections and audits.
Prepare/Review SOPs.

Secondary Responsibilities:
Manage real-time Trend entries and APQR (Annual Product Review) analysis.
Lead on-the-floor manufacturing activities.
Actively participate in Vendor Management.
Contribute to Regulatory Filing efforts.
Deliver training to enhance quality performance.

Sr. Executive - Manufacturing (recombinant Vaccine), Cadila pharmaceuticals ltd

2013 — 2015

Recombinant vaccine (RSV,H1N1, SEASONAL FLU, RABIES) Manufacturing with sf9 insect cell USP & DSP
process. Equipment Qualification, GMP area qualification and maintenance and Quality documentation. DOE study for perfusion proess.

Sr. Supervisor - Manufacturing (Microbial / Mammalian), Zydus Biologics Ltd

2009 — 2013

Microbial Fermentation (USP & DSP) Mammalian cell culturing (USP) GMP Documentation, Quality
Assurance, Equipment Qualification, GMP area qualification and maintenance and Quality documentation. Scale up process.

EDUCATION

SCHOOL OF SCIENCE - GUJARAT UNIVERSITY

2007 — 2009

r-DNA technology, Animal cell Culture, Plant tissue culture, Molecular biology. Genetic engineering & Cloning, IPR & IPP, Cell biology, Bioinformatics, Immunology, Enzyme technology, Genomics & Proteomics, Environmental & Agro Microbiology, Biochemistry, etc.