Manufacturing Quality

MAHESH KALWANI

E-mail: *************@*****.***

Cell: 617-***-****

OBJECTIVE

Looking for a position in the Pharmaceutical/Biotech Industry for growth

and career development.

PROFESSIONAL EXPERIENCE

Genzyme Corporation, Framingham, MA, USA

Mar 2013- Present

Senior QA Compliance Specialist

. Regularly reviewed and approved batch production records for

Compliance with cGMPs.

. Conducted audits and reviews/analyzed technical data and technical

documentation including purification and cell culture batch records,

QC analytical data, validation documentation and all related documents

to support product release.

. Wrote and improved SOPs (Standard Operating Procedures) and OJTs (On

the Job Training).

. Assist in regulatory audits, Conducted walkthroughs and internal

audits in Cell culture, Media, Equipment prep and Purification

departments and represent QA operations.

. Knowledge of FDA, European regulations, Japanese regulations and

Canadian regulations

. Technical Software Tools used in this position - Livelink (Document

Management System), iLIMS (Laboratory Information Management System),

Trackwise (Deviation, CAPA, CCR system), MFG Pro(Material Management

System), PI (Manufacturing Process Control System)

. Trained new employees to make them Quality Professionals.

. Took an active role in Deviation, Investigations, Change Controls and

CAPA (corrective and preventive actions). Initiate deviation and

perform thorough investigations, Identify root cause (5 Why's, Fish

Bone) and implement CAPA.

. Responsible for conducting Quality Exception (QE) investigations

generated due to manufacturing operations exceptions, environmental

monitoring excursions, and manufacturing maintenance exceptions.

QA Specialist Mar

2011- Mar2013

. Writing/Editing SOPs and OJTs.

. Worked on Master Batch Record Changes, Action Notices and Cleaning

Verification.

. Supported Manufacturing departments with QA on the floor support.

. Responsible for conducting Quality Exception (QE) investigations

generated due to manufacturing operations exceptions, environmental

monitoring excursions, and manufacturing maintenance exceptions.

. Root Cause Analysis and CAPA

. SOPs, Deviations, CAPA, Change Control and Master Batch record

Changes.

Shire HGT, Lexington, MA, USA

2011- 2011

Cell Culture Tech II

. Worked on the Ultra filtration Skid. [pic]

. Enhanced my good manufacturing and good documentation experience.

. Editing and generating SOPs,

. Learned the process of cell culture using Roller Bottles.

. Took an active role in Deviation and CAPA Management.

Biogen Idec, Cambridge, MA, USA (Veritude)

2009 -2011

Cell Culture Associate III (Contract)

. Gained experience working under strict cGMP regulated environment.

. Worked with minimal supervision according to standard MBRs and SOPs

under cGMPs.

. Performed routine calibration, preventive maintenance and trouble-

shooting on Analytical Instruments such as Cell Counter, Blood glucose

analyzer, osmolarity meter, pH meter, conductivity meter.

. Obtained experience working with aseptic techniques in sterile

environment.

. Performed environmental monitoring of the clean areas.

. Worked in Cell Culture department in multiproduct manufacturing

facility and operated small as well as large scale Bioreactors.

. Performed SIP validations, cleaning validations and engineering run

studies on equipment and performed related QC sampling (Endotoxin,

Bioburden, TOC Swabs)

. Extensive experience working on DeltaV automation control system.

. Experienced with weighing and mixing buffer and media, operating mix

tanks, autoclaves, glasswashers and COPbaths.

Northeastern University, Boston, MA, USA

2008- 2009

Research Assistant

. Worked in the Lab of Dr. Rebecca Carrier on the project involving drug

release studies from various emulsion formulations. [pic]

. Characterized different emulsions by measuring particle size using

microscopy.

. Obtained hands on experience of working on UV spectrophotometry, pH

metry.

. Obtained thorough training in experimental design and organizing

presentations.

. Prepared protocols and analyzed data using Excel and SPSS.

. Completed Lab safety and Chemical Hygiene training as well as

Hazardous waste management training in Northeastern University.

Astral Pharmaceuticals Ltd, Vadodara

2006 -

2006

Quality Associate

. Gained experience as a QA person in the GMP facility involved in the

production and evaluation of Tablets, Capsules, syrups and semisolid

preparations.

. Performed various quality control tests such as friability test,

hardness test, disintegration test, dissolution test, weight variation

test.

. Compiled and Maintained test results data to support possible future

investigations.

. Worked on Deviations and CAPAs.

Vital Pharmaceuticals Ltd, Anand

2007

- 2007

Quality Associate

. Performed statistical sampling and testing of raw materials, in

process samples and finished products.

. Cross training in various departments including Manufacturing and QC

. Gained experience or working in Clean Rooms under aseptic conditions.

. Obtained experience in Deviations, Investigations and CAPA.

EDUCATION

Northeastern University, Boston, MA, USA

2007- 2009

Master of Science in Pharmaceutical Engineering

Sardar Patel University, Anand, Gujarat, India

2003- 2007

Bachelors of Pharmacy (BS)

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