GRISHMA PATEL

Grafton, MA ac9qv1@r.postjobfree.com Ph. # 215-***-****

SUMMARY

To obtain a position in a Pharmaceutical/Biotech/medical device industry that provides an opportunity to utilize my technical skills to achieve regulatory compliant quality product and contribute towards prospective growth of the company.

SKILLS

Quality Skills

Software Skills

SOP writing

TrackWise

Deviations, CAPA

Document Management Systems

Root Cause Analysis

Batch Record Review and Batch Release

iLIMS

Material Management System

Minitab

MS Office

Electronic Batch Record System

EDUCATION

Institute of Advance Study in Education, India Oct 2004 - Oct 2008

Bachelor of Science

EXPERIENCE

Pfizer (TalentBurst Staffing ), MA June 2018 - Present

Manufacturing Associate

Support upstream and downstream manufacturing activities for production

Perform activities involved with cell culture expansion, media prep and buffer prep areas in order to prepare media and buffer for the production

Perform purification activities like filtration skid, chromatography skid

Perform activities involved in equipment prep areas

Perform automated and manual CIP/SIP of the buffer and media tanks

Perform depyrogination of various equipment by operating Depyro equipment

Operate equipment like parts washer, autoclave, media/buffer prep tanks per SOP

Operate sample testing equipment like pH meter, conductivity meter, osmometer and turbidity meter

Coordinate preparation activities and align materials for the next day activities

Document manufacturing activities per cGMP in batch records

Perform manufacturing review of completed batch records for the release of batch

Draft and review manufacturing SOP

Medtronic, CT Aug 2014- June 2017

Manufacturing Associate

Performed manufacturing steps to make buffers and reagents in controlled environment

Performed cleaning of the buffer tanks

Operated pH and conductivity meter to test the solutions

Operated machines required in assembly of various medical devices

Recorded manufacturing production steps in batch record with Good Document Practices

Maintained safe and clean work environment by following current Good Manufacturing Practices (cGMP) and standard operating procedures

Documented production by completing forms, reports, logs and records of equipment and batches

Reviewed production batch records to verify the compliance with regulations

Participated in investigation of deviations and implementation of CAPA

Responsible for writing and approval of standard operating procedures.

Providing effective training and guidance to new team member.

N.K Pharmaceuticals, INDIA Jan 2008- Aug 2009

Internship

Examined, participated, and observed manufacturing and packaging of parenteral products

Released batches as required per FDA regulations

Learned about generation and maintenance of batch record documentations

Observed and understand manufacturing facility management

Understand GMP aspects in manufacturing process of Parenteral

Learned quality achievement in process, observed and implement SOP in real process

Trained in manufacturing process of Vials from raw material to finished product

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