Quality Control Manufacturing

VENKATESH CHERUKUMALLI

*** ***** ***** ** ********* NY 12095

Phone: 607-***-****

Cell: 518-***-****

Email:********@*****.***

Dear Sir/Madam

With regards to the advertised position in QA /QC please find attached my resume for your

consideration.

My credentials include a Master’s degree in Chemistry with over 18 years of Pharmaceuticals

experience in a variety of positions with in quality control, production and QA departments. I am

well versed in working under GMP,GDP, GLP’s and have extensive experience operating

laboratory instruments typical of a pharmaceutical firm including HPLC, GC, FTIR and

Dissolution Apparatus and review the DATA.

Furthermore I have an extensive work history in GMP production environments and have

produced commercial products using leading edge pharmaceutical processing machinery like

FBD,blenders,chilsonators,encapsulators, and API manufacturing equipment like Reactors and

centrifuges with additional scheduling, planning and organizational skills.

I am confident that my extensive professional experience coupled with my significant education

and training will contribute significantly to the success of your organization

I look forward meeting with you to further discuss my qualifications and how I would be an asset

to your organization when given the opportunity.

Regards,

Venkatesh Cherukumalli

Venkatesh Cherukumalli ********@*****.*** 607-***-****,cell:518-***-****

Professional Summary:

QA&QC

1. Master of Science with over eighteen years of experience in pharmaceutical industry ( API and

Solid Dosages) with strong knowledge in QA, Quality Control and Production areas.

2. Experienced in FDA audits for regular cGMP and preapproval Audits for ANDA filings

As a part of QA team, reviewed and released (manufacturing and packaging) batch records

4.Experienced in internal/external AUDITS (ISO-9002/FDA)and handeled CCRs,Market

complaints,Process Deviations,OOS OOT investigations,Vender Complaints

5. Hands on experience in lab instruments like HPLC, GC, FTIR, Dissolution, Asoma X-ray Karl

Fisher, Polarimeter, friabilator and hardness tester and calibration of lab equipment.

Reviewed all analytical reports and production batch records and released the products for shipping,

addressed quality incident/deviation reports

6. Involved in internal AUDITS for OOT,OOL and OOS yields and results in manufacturing and QC

7. Experienced in Analytical Method Developments and Validation for Various Products

8. Experienced in preparing and reviewing analytical data against specifications (FP/RM/IP/C of A’s)

9. Good working knowledge in cGMP, GLP, GDP, Hygiene and Sanitation procedures.

10. Refined troubleshooting regarding instrumentation and laboratory techniques

11. Comprehensive understanding of GLP, aseptic techniques & laboratory safety

12. Involved in the testing of various solid dosage formulations and sponges for, Assay, Dissolutions,

CU, Related Compounds tests and documented results as per SOP

13. Performed the analysis of Raw materials (API), In process and Finished products samples in

compliance with in-house methods/USP/BP/EP requirements

14. Experience in calibration of laboratory instruments like pH meter, balances, KF titrates etc.

15. Expertise in common analytical techniques chromatographic systems, Empower, LIMS, Cerity,

Chemstation,Totalchrom, BPCS and FDA/HPFBI compliance knowledge

.

PRODUCTION

1. Proficiency in operating manufacturing equipment used to produce commercial product using

Fluid Bed Pellet manufacturing / wurster Coating equipment, Encapsulators, granulators and

Reactors(GLR’sSSR’sLLR’s),centrifuges,filters,dryers in API manufacturing

2. Strong working knowledge of cGMP and regulatory requirements for Canada, the US and Europe

3. Maintained relevant documentation as per cGMP

4. As a part of Document review team in mfg, reviewed and reconciled (manufacturing and

packaging) batch records

5. Reviewed all production documents prior to final release

6. Responsible for operation, disassembly and mounting of Pellet manufacturing and pellet and tablet

coating equipment including cleaning of parts and accessories as per internal SOP’s

7. Worked on products in API mfg for NAPROXEN, CIPROFLOXACIN, IBUPROFEN,

OMEPRAZOLE, DILTIAZEM, ONDENCETRON and SUMATRIPTON.

8. Generated & maintained accurate record keeping for monitoring of equipments and environmental

conditions as per cGMP requirements.

Venkatesh Cherukumalli ********@*****.*** 607-***-****,cell:518-***-****

WORK HISTORY

POSTION COMPANY DURATION

QA\QC Supervisor OHM LABS NY Apr 2007-Till date

PROCESSING McNeil CANADA Nov 2006- Mar 2007

(Contract)

QA- ASSOCIATE PATHEON Inc, CANADA May 2006 – Oct 2006

MFG TECHNICIAN NOVO PHARM (TEVA), CANADA JAN 2006 MAY 2006

(Contract)

QC -CHEMIST APOTEX Inc, CANADA Mar 2003 – Oct 2005

PRODUCTION Operator APOTEX Inc, CANADA July 2001 -Mar 2003

Sr. Executive QA&QC AUROBINDO PHARMA Ltd. May1999 – Mar 2001

Sr. Executive production AUROBINDO PHARMA Ltd. July1998 – Apr 1999

PRODUCTION Officer NATCO PHARMA Ltd. Nov 1993 - July1998

QC&A Chemist GLOBAL DRUGS pvt. Ltd. Aug1990 -Nov 1993

Academic Qualifications:

Master of Science in chemistry, Osmania University, India, 1988-1990.

Assessed as 4 years bachelors degree in chemistry by UNIVERSITY OF TORONTO

4Bachelor of Science in chemistry,botany,zoology Osmania university, India, 1984-1987

Continuing Education:

* Advanced Pharmaceutical Manufacturing Technology Seneca College

* Laboratory Assay methods Seneca College

* Introduction to Regulatory Affairs Seneca College

Memberships:

Member in good standing, Canadian society for chemistry

References-Available on request

Contact this candidate