Quality Assurance Manager

RESUME

Jitendrasing Rajput.

Address (Current): *-132, Seshikrishna

Murthy Nivas, Chanda nagar, Hyderabad

Andra Pradesh, Pin – 500050.

Mb. No. : 955*******

E mail : abn9pw@r.postjobfree.com

abn9pw@r.postjobfree.com

OBJECTIVE

To work in professional environment wherein my skill sets will add value to the organization & my career.

EDUCATIONAL QUALIFICATION

M.Sc. Microbiology (First class) – North Maharashtra University (School of Life Science)-Jalgaon (N.M.U.) -

Maharashtra- in 2004.

PROJECT EXPERIENCE: - Successfully completed the dissertation work on “Effect of various Biopolymers

on Rifamycin Biotransformation by using Curvalaria lunata” during the academic year 2003-04.

Paper published in Journal of pure & applied microbiology April 2008, Vol.2.

B.Sc. Microbiology (First class) from R.C. Patel College- N.M.U. Jalgaon-Maharashtra in 2002.

CARRIER SUMMARY (Total 8.0 Yrs)

Company Designation Experience

Dr. Reddy’s laboratories Ltd. Biologic Division, Sep. 2010 to till date

Asst. Manager-QA (Validation)

Hyderabad

Intas Biopharmaceuticals Ltd. Ahmadabad. Executive-QA (IPQA & Audit compliance) Oct.2008 to Sep. 2010.

Cadila Pharmaceutical Ltd. Ahmadabad, Sr. Technical Supervisor-QA (Validation) Dec 2006 to Oct. 2008.

Wockhardt Ltd. Daman. QA Officer (Microbiologist) Jun. 2005 to Nov. 2006.

Work Summary

• QC Microbiology:-Microbiological analysis, Validation of microbiological analysis methods,

Environmental monitoring.

• Quality Assurance:--

- Handling of change controls, CAPA, and deviations.

- Preparation of Apex Document (SMF, VMP, Quality Manual), Designing of Documentation.

- Gap analysis and Audit compliance

- Process Assurance

- Batch Release

• Qualification of equipment, Area Qualification, Aseptic Process simulation, Thermal

Validation.

• Validation of utilities such as AHU System, Water System, compressed air, CO 2, O2 & Nitrogen

gas.

• Thermal validation

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• Exposure of dosage forms

- Exposure of recombinant biotech products: - Erythropoietin, Interferon, Insulin, Darbepoetin, Rituximab, GCSF,

peg GCSF.

- Injectable products:-Vial, Ampoule, PFS, Sterile Dry Powder.

- OSD: - Tablet, capsule & liquid oral.

Audit Exposure: Internal audit and External audit of various regulatory authorities like WHO-Geneva, MHRA,

TGA, Ukarine, IDMA, INVIMA,GCC, ANVISA Brazil, MCC, GCC, USFDA etc.

INDUSTRIAL TRAINING (6 month)

Organization: Kopran pharmaceuticals Ltd. Khopoli, Maharashtra.

For 6 months Industrial training (Quality control-Microbiology) from Dec. 2004 to Jun 2005.

PROFESSIONAL EXPERIENCE

1. Dr. Reddy’s laboratories Ltd. Biotechnology division (API & Formulation), Hyderabad

Manufacturing of Drug substance and sterile drug product of recombinant product such as Rituximab, Darbapoetin,

GCSF and Peg GCSF.

Job Responsibilities

• Project Exposure: - Coordination and execution of commissioning & qualification activities of new facility

(Cell culture manufacturing facility).

• Preparation and review of SOP’s, Validation protocol and all system documents.

• Aseptic process simulation activity scheduling, monitoring and report preparation.

• Area Qualification of Sterile & Non –Sterile Area.

• Validation of utilities such as AHU System, Water System, pure steam, compressed air, Nitrogen gas.

• Prepare / Review of VMP, FVMP, FCMP, IQ, OQ and PQ documents

• Reviewing the URS, QAP, DQ, FDS, FAT, SAT, MC and CTP documents & related drawings.

• Training on validation documentation.

• Investigation & report preparation in case of failure during the qualification.

• Ensuring adequate transfer of systems and documentation to all new facilities.

• Preparation and execution of the Revalidation checklist, Validation Schedule, Calendar and maintaining their

records.

• Thermal validation

• Compliance of internal and external audit observation.

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2. Intas Biopharmaceuticals Ltd. Ahmadabad.

Intas Biopharmaceuticals is India's first and only biopharmaceuticals company to receive European Union -Good

Manufacturing Practice (EU-GMP) certification for its manufacturing facility . Also certified MCC, GCC,

Sudan FDA, Yemen FDA, Indonesia-FDA, Jordan, Sudan, Belarus FDA is manufacturing DS & DP of

recombinant product such as Interferon, erythropoietin, GCSF, Peg GCSF.

Job Responsibilities

• Overall monitoring of manufacturing process & technical review of associated documentation related to batch

release of finished product.

• Preparation and review of SOP’s, Validation protocol and all system documents.

• Handling of change controls, CAPA, and deviations.

• Transport Validation

• Taking actions on regarding gaps identified externally and internally for USFDA.

• Ensuring cGMP compliance, implementation of quality system.

• Investigation & report preparation in case of batch failure.

• Preparation, compilation & monitoring of apex document such as Site Master file, Validation Master Plan.

• Media filling activity scheduling, monitoring and report preparation.

• Review of BPCR & MPCR of new product.

• Performing internal audits & follow up for closing of audit observations.

3. Cadila Pharmaceutical Ltd. Ahmadabad.

Cadila Pharmaceutical Ltd.(certified UK-MHRA, MCC, cGMP, TGA)is manufacturing Insulin & Streptokinase

Formulation (Biotech Product),oral solids(Tablet, Capsule) and Injections

Job Responsibilities

• Media filling activity scheduling, monitoring and report preparation.

• Review, updating and Ensure facility setup drawings such as Area classification, Area Differential Pressure &

Air flow direction, AHU Allocation, Man/material Movement, Civil Layout, Purified Water/WFI Generation and

Distribution system

• Validation of utilities such as AHU System, Water System, compressed air, Nitrogen gas.

• Qualification and Revalidation of equipments like Autoclave, DHS, Tunnel, Laminar air flow unit, Ampoule/Vial

washing machine, SIP, CIP, Pressure Vessel.

• QC – Microbiology responsibility:-

Coordination and review of validation of microbiological analysis methods (Sterility test, MLT, BET,antibiotic

assay Effectiveness of sanitizing agent)

Validation of environmental monitoring by Settle plate, Surface test, air sampling.

Ensure the Documentation of all routine analysis, validations and calibration as per regulatory requirements.

Project Exposure:-A team member of new Facility setup for penicillin manufacturing with individual Quality

control unit.

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4. Wockhardt Ltd. Bhimpore Nani Daman -396210 (U.T.).

Wockhardt Ltd.(certified UK-MHRA,cGMP) is manufacturing Erythropoietin & Interferon Formulation (Biotech

Product), oral solids and Injections.

Job Responsibilities

• Technical Experience:- ELISA test, MLT, BET, Sterility, Antibiotic & Vitamin Bioassay, Culture Identification

and Maintenance.

• Microbiological analysis of RM/FP &in process samples.

• Environmental Monitoring by Settle plate, Forced air sampling, Surface swab.

• Calibration of microbiology laboratory instruments.

• Preparation, review & updation of SOPs & STPs related to microbiology.

• Supporting the QA team leader in the internal audit

• Qualification of Autoclave, Dry Heat Sterilizer, Lamina Air Flow unit & equipment of parenteral department.

PERSONAL STRENGTH

Logical thinking & Positive attitude.

Effective communicative skill and leadership quality.

Good concept developer & critic.

Maintaining good interpersonal relationships & active involvement in any sort of groups.

Able to work independently with minimal supervision.

PERSONAL DETAILS

Date of Birth : 01 June 1981

Fathers Name : Rajput Anansing Daulatsing

Marital Status : Married.

Language known : Marathi, Hindi, English, Guajarati.

Permanent address : A/P – Uparpind, Tal – Shirpur, Dist. – Dhule. Maharashtra, Pin – 425405.

Nationality : Indian

REFERENCES

Mr. Rohit Sompura Available on request

Sr. Manager –QA

Kemwell Biopharmaceuticals limited, Bangalore

DECLARATION

I hereby declare that the above-mentioned information’s are authentic and true to the best of my knowledge.

DATE: . PLACE: .

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