raja resume_m.pharm_qa_11 years experience

RESUMEGOWHAR RAJA. VANDANAPU M. PHARM (QA)Mobile: +91-9618626012 / 9133396820E-mail: [email protected] [email protected]://IN.LINKEDIN.COM/PUB/GOWHAR-RAJA-VANDANAPU/18/38/482/

Respected sir / Madam,

I Gowhar Raja. Vandanapu would like to present my self to work in your esteemed organization in light of my

qualification with Eleven years experience.

In order to apprise you of my detailed academics and experience, I am here by enclosing my Curriculum Vitae to

your kind perusal.

If given an opportunity to serve in your world-class organization, I will prove myself with best of my abilities and

hope to win your faith very soon.

Thanking you

Yours truly,

(Gowhar Raja. Vandanapu)

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mailto:[email protected]



JOB OBJECTIVE

M. Pharm (QA) with 11 years experience in 100% regulatory markets (USA, EUROPE, SOUTH AFRICA and others) for seeking managerial level assignment in Quality Assurance department, Contact manufacturing, with a growth

oriented role in leading frontline Pharmaceutical organization.PROFESSIONAL PROFILE

A keen employee with about 11 Years of experience in Quality Assurance cGMP maintenance in the Pharmaceutical Industry.

Currently serving AUROBINDO PHARMA LIMITED (Formulation division-Unit 12) as Deputy. Manager - Quality Assurance.

Experience in Implementation of quality management system, handling of relevant documents like Market complaints, Corrective and preventive actions, change controls, periodic Internal and external quality audits deviations, cross functional investigation on quality issues, etc….

Experience in Validation and documentation. Risk Assessments preparation and vendor audits. Encompassing strong leadership and successful team build – up capabilities, combined with excellent technical,

communication and presentation skills. Expert in inspiring others to build ideas, refine concepts, connect in a spirit of consensus and imagination. While operating independently desired goals, achievements, results are communicated to tem members,

management, most importantly using oral and written communication skills. Resourceful problem solver with proven ability to bring quick resolution to challenge situations. Experience in Quality Assurance Shop floor activities in both manufacturing and packing operations.

EXPOSED TO PHARMACEUTICAL DOSAGE FORMS

Solid oral dosage forms (Tablets, Capsules,Dry powder Syrups). Sterile dosage forms ( Dry powder Injectables, Lyophilized Injectables). Metered dose Inhalers.

CAREER PROFILE

ORGANIZATION DESIGNATION DURATION

Aurobindo Pharma Limited - Hyderabad DEPUTY.MANAGER - QUALITY ASSURANCE MAY. 2010 TO Till date

Alembic Limited - Vadodara SR. EXECUTIVE - QUALITY ASSURANCE SEP.2008 – APRIL.2010 Cadila Pharmaceuticals -

Ahmedabad EXECUTIVE - QUALITY ASSURANCE OCT.2006 – SEP.2008

Cipla Limited - Goa OFFICER - QUALITY ASSURANCE JUNE.2005 – SEP.2006

CORE COMPETENCIES

Quality Management system In- process quality assurance Quality Audits Validation Review of Manufacturing and Analytical

documents Handling of new projects

Audits Faced USFDA – 04 Times MHRA / FIMEA – 05 Times TGA – 03 Times Anvisa – 03 times MCC south Africa - 02 WHO – 02 times and other many customer audits.

CONTD……………..

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PROFESSIONAL EXPERIENCE RELATED TO QUALITY MANAGEMENT SYSTEM

Handling of market complaints for all regulated markets. Handling of field alerts to USFDA and preparation of complaint trends (Quarterly, Annually

and comprehensive reports for reoccurring complaints). CAPA generation and follow – up for implementation through Automated QMS system. Periodic review of implemented CAPA effectiveness. Handling and review of change controls through automated QMS system. Handling of internal audits, vendor audits and Support for regulatory audits. Handling of temperature excursions during transit of consignments. Conducting transportation studies along with stability department. Review of stability protocols and reports. Preparation Risk Assessment analysis using different tools such as Fish Bone and (FMEA)

Failure Mode and Effect Analysis. Handling and review of Failure Investigations in shop floor. Review of Exhibit batches manufacturing and packing records for regulatory submissions. Handling of regulatory queries. Review of packing material art works received from packing development. Verification of COA and Batch release, sharing of related documents and samples to

concerned customers. Response to customer queries. Preparation, review and revision of site master file.

PROFESSIONAL EXPERIENCE RELATED TO VALIDATION

Preparation, review and execution of process validation protocols and reports for all regulatory markets.

Preparation, review and execution of cleaning validation protocols and reports. Preparation, review and execution of hold time validation protocols and reports. Handling of validation and stability samples. Handling of HVAC validation and facility qualifications. Temperature mapping of new and renovated facilities. Handling of Equipment validation (Preparation of IQ, OQ and PQ protocols for both sterile

and non sterile dosage forms ). Review and updation of master validation plan. Preparation of validation schedules. Review of quality control reports related to validation of activities. Preparation and review of stability protocols and stability samples. Review of Analytical Method validation documents related to new products and cleaning

validation. Monitoring and maintenance of stability chambers regularly.

PROFESSIONAL EXPERIENCE RELATED TO DOCUMENTATION

RESPONSIBILITIES ACTIVATES RELATED TO DOCUMENTATION AND VALIDATION

Review of all master documents related to batch manufacturing and packing records for all dosage forms (Tablets, capsules, liquid orals, Injectables)

Review of new and revised packing art works. Preparation and review of Standard Operating Procedures. Preparation and review of master batch manufacturing records and packing records. Issue and control of documents(Batch manufacturing, packing records and log books)

CONTD……

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Line clearance in manufacturing and packing area. To perform the sampling activity of Semi-finished and finished products during the

manufacturing and packing operation. Review of executed batch manufacturing and packing records on shop floor. Handling of customer samples and export documents. Handling of online non – conformances and incidence. Monitoring and sampling of exhibit batches and finished product samples.

PROFESSIONAL EXPERIENCE ON SHOP FLOOR

SOFTWARE USED

Quality module in ERP(SAP 6.0) FoxPro for BMR and BPR’s issuance

LIMS (Caliber) Quality Management System (Metric steam)

KAYE Validator (GE sensing) for sterile equipments

INSTRUMENTS HANDLED

HPLC with Class VP soft ware

Tablet hardness tester

Leak test Apparatus

Other In -process quality equipments

TRAININGS ATTENDED

Participated in Various training programs on cGMP/GLP. Conducting self inspections by INSIGHT GMP Systems. cGMP and qualification training by Lachmen consultants. Sterile operations training by Nigel halls.Regulatory audits faced: Successfully faced regulatory audits such as US FDA, UK MHRA, MCC, and WHO – Geneva and Brazil – ANVISA etc.Customer audits faced: Astra Zeneca. SAGENT Pharmaceuticals – USA. Sanofi Aventis and Other many customers……

ACADEMIC CREDENTIALS

M. Pharm (Quality Assurance) with 7.9CGP. B. Pharm (Pharmacy Subjects) with 67.8%. D. Pharm (Pharmacy Subjects) with 72%.

IT SKILLS AND HOBBIES

MS office (MS Word, Excel, Power Point). Inter net browsing Reading books, News papers, Magazines. Watching TV and playing chess.

PERSONALITY TRAITS

Excellent verbal, written communication and analytical skills. Strong believer of business success is closely associated with excellent human relationships. Known for my high degree of energy and passion. Highly passionate about sharing knowledge and experience. Very high tolerance level.

CONTD……

AREA OF INTEREST TO WORK

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RESUMEGOWHAR RAJA. VANDANAPU M. PHARM (QA)Mobile: +91-9618626012 / 9133396820E-mail: [email protected] [email protected]://IN.LINKEDIN.COM/PUB/GOWHAR-RAJA-VANDANAPU/18/38/482/ Quality Assurance in manufacturing plant level. Quality assurance contract manufacturing / external supply. Corporate Quality Assurance ( Validation, vendor audits, Systems developments). Regulatory Affaires.

REFERENCES

Mr. Srinivas Kanduri Mr. Tapan Kumar jena Manager – Global Quality Management Assistant Manager Dr. Reddy’s - Hyderabad Formulation Research and development Mobile: 8008002554 TORRENT PHARMA - AHMEDABAD Email:[email protected] Mobile : +91-8790476421

Mr. Ganesh Nomulwar Mr. M. Gopi Reddy

Manager - COQA (Asia Pacific) Vice President Pfizer (Zoetis) Quality compliance Mobile : +91-9966645643 / 8179472943 Cipla Limited - Mumbai Email:[email protected] [email protected]

Mobile : +91-8879974466

PERSONAL DETAILS

Nationality IndianLanguages Known Telugu, Hindi, English and KannadaMarital Status MarriedPresent Address Flat No. 208, Second floor, MAA Heights, HMT Swarnapuri Colony

Near Community Hall, MIYAPUR, HYDERABAD – 500 049Andhra Pradesh, India.

Passport Status Readily available.

DECLARATION

I hereby declare that the information that I have furnished is authentic, and true to the best of my knowledge.

GOWHAR RAJA. VANDANAPU

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raja resume_m.pharm_qa_11 years experience

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