August 30, 2010

SUBUDHI RAJENDRA K.
40556 Ramblewood ct
Canton, MI - 48188
Tel: (734-788-7749
E-mail: rsb17d14@westpost.net
________________________________________________________________________
Re: Applied for production supervisor
Job ID: Production Supervisor
Job Number: 2008171
Dear Sir/Madam,
Currently, I have an employment with Caraco Pharmaceutical Laboratories Ltd. Loc
ated in Detroit, Michigan. I am working in a Formulation Development, Manufactur
ing and Packaging profession since January 2001. My previous employment, prior t
o Caraco Pharmaceuticals, was in a Pharmaceutical manufacturing of solid dosage
form and as a production officer, I was responsible for manufacturing, packaging
, planning and scheduling of solid dosage form of Tablet and Capsules. I am see
king position in a manufacturing profession, matching my qualifications and Prof
essional experience, for further career advancement.
Enclosed is resume, outlining qualifications and professional experience, for
careful
Consideration. I would appreciate the opportunity of a personal interview to
discuss my
Professional experience. I can be contacted at (734) 788-7749.
Thank you very much for your time
Sincerely,

Subudhi Rajendra K.
734-788-7749
Encl.

SUBUDHI RAJENDRA K.
40556 Ramblewood Ct
Canton, MI - 48188
Tel: (734)788-7749
E-mail: rsb17d14@westpost.net __________________________________________________
____________________________
AREA OF EXPERTISE
1 Daily and monthly planning/scheduling for usage of various pieces of manufactu
ring, filling equipment and packaging lines
2 Perform audits of products and processes to identify areas for improvement inc
luding manufacturing and packaging
3 Working as chemist in Formulation development department with ANDA project tea
m
4 Wrote numerous protocols, change controls and investigation reports
5 Manufacturing representation for Sales and Operations Meeting
6 Writing and updating SOPs as per US FDA Compliance
7 Review and write the batch manufacturing and packaging records, performance qu
alification (PQ) and validation protocols and reports
8 Troubleshooting of various issues relating different manufacturing and packagi
ng processes
9 various control substances as per DEA regulations
10 Ability to work in a team-based environment, decision making and critical thi
nking
11 Ability to simultaneously manage multiple tasks/priorities with minimal direc
tion provided by management
PROFESSIONAL EXPERIENCE
Caraco Pharmaceutical Laboratories, Ltd. January 2001a" July 2002
Detroit, MI a" USA a" Chemist Formulation Development
Reporting to manager, responsible for Formulation development of new product and
filling for ANDA, develops the products for Bioequivalence (Pre-Exhibit and Exh
ibit Lot) study before filling and submission for ANDA approval to FDA
Caraco Pharmaceutical Laboratories, Ltd. August 2002a" September 200
3
Detroit, MI a" USA a" Supervisor Manufacturing and Packaging
Reporting to Manufacturing Head, responsible for manufacturing and packaging for
manufacturing and packaging of scheduled products for multiple compression, coa
ting and packaging lines and in process inspection including final review of bat
ch manufacturing and batch packaging records (BMR and BPR). Also managed warehou
se activities which include issue and receiving of packaging non printed compone
nts.

Caraco Pharmaceutical Laboratories, Ltd. October 2003 a" November 200

6
Detroit, MI a" USA a" Assistant Manager Manufacturing
Reporting to Manufacturing Head, responsible for coating, encapsulation and pack
aging of scheduled products. Also performed the final review of BMR and BPR.Cord
ination with contract packaging facility. Daily contact with sales and marketing
for deliver the finished product in timely manner. Attend the daily production
and planning meeting with COO, sales and marketing and QA team for daily status
of packaged and finished product.
Caraco Pharmaceutical Laboratories, Ltd. December 2006 a"March 2
008
Detroit, MI a" USA - Assistant Manager Planning and Scheduler
Reporting to Associate Director Manufacturing, responsible for planning and sche
duling the products as per sales and marketing forecast. Prepare the monthly and
 weekly planning for manufacturing and packaging per bottle counts requirements
by sales and marketing. Schedule the product packaging requirements for contract
packaging facility as per requirements by sales and marketing. Final review the
BMR and BPR. Preparation of Monthly report and work in process (WIP). Attend th
e daily production and planning meeting with CEO, sales and marketing and QA tea
m for daily status of packaged and finished product. Performing internal system
ERP transactions to reflect the current actual physical status of the intermedia
te and finished products.
Caraco Pharmaceutical Laboratories, Ltd. April 2008 a" Till
date
Detroit and Farmington Hills, MI a" USA a" Manager Packaging, Planning and Sched
uling.
Reporting to Operation Head, responsible for providing managerial support at pa
ckaging facility in Farmington Hills location. It includes implementation of dai
ly packaging operations, Scheduling of products for seven packaging lines, month
ly planning for manufacturing and to provide the status of various stages of pro
ducts to operation committee, Ensure optimum productivity and utilization of pac
kaging lines through daily leadership, provide quality and regulatory guidance a
nd leadership to deal with compliance issues, auditing packaging line to ensure
plant compliance and FDA regulations.
New packaging line installation with the help of engineering and validati
on team, New product validation after ANDA approval from FDA, provide the traini
ng to all packaging and manufacturing supervisor in ERP(Enterprise Resource Plan
ning) module, attend the operational committee meeting, attend the weekly meetin
g with sales and marketing, commercial and distribution. Daily monitoring of pac
kaging schedule, productivity and quality issue, Prepare the monthly and work in
process (WIP) report.
Additional responsible like contact with all packaging equipments vendor and pri
nted non printed components vendor, Quarterly audit of packaging components vend
or, Supervision and training to the Sub-ordinates.

Sun Pharmaceutical Laboratories, Ltd. April 1999 a" December 20

00
Silvassa, UT of D and H a" INDIA a"Production Officer, Manufacturing
Reporting to production manager, responsible for managing four junior production
chemists and 60 operators, working with formulation development team with vario
us new product developments, performed the IQ/OQ/PQ on various new equipments wi
th technical services team; perform the cleaning validation program and helping
the preparation of cleaning validation matrixas, conduct the training for newly
hired junior production chemists and operators

Ipca Laboratories Pvt Ltd March 1998 a" April 1999

India a" Jr Production officer
Reporting to manager operation and responsible for managing twenty operators and
worked as independent shift in charge, performed the IQ/OQ/PQ on various new eq
uipments with validation team and prepared the facility for certification of MCA
(U.K), MCC (South Africa), worked closely with validation team and successfully
validated different solid oral products.
Micro Labs Ltd March 1998 a" April 1999
India a" Production chemist
Reporting to production manager, responsible for dispensing and compression supe
rvisor with twenty five machine operators, monitoring the daily dispensing and c
ompression activity, preparation of monthly compression output and number of lot
s dispensed.
PROFESSIONAL COURSES AND TRAINING
1. Training for production system (ISO 9001)", Mumbai, India, 1998
2. Introduction and update to Good Manufacturing Practice (GMP)", Mumbai, India,
1999
3. Training for manufacturing and packaging system by Indian Drug Manufacturing
Association (IDMA).
4. cGMP training by Lachman Consultants USA
EDUCATION
Berhampur University, India April 1992 a
" May 1996
B.Pharm (Bachelor of Pharmacy) Pharmaceutics.