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CHIRAG BHATT

****, ***** ***** *****, **********, Kentucky, 40229 812-***-**** actwin@r.postjobfree.com C A R E E R OB J E C T I V E

To become a successful Quality Assurance Professional and shall utilize my skills to ensure cGMP systems in the manufacturing of the product for the benefit of the firm and to provide best quality products to make a world a better place.

C O R E C OM P E T E N C I E S

Excellent interpersonal, communication, managerial and organization skills.

Well versed with various Aseptic manufacturing processes, Media fill simulations, cleaning validation, documentation system, SOP’s and cGMP regulations (21CFR, PIC/S-GMP, ICH,WHO GMP.)

Quality System (QS): Site Master File, Validation Master Plan, Risk management system

(FMEA), APQR, Handling of Change Controls, Internal Audits, Handling and Investigation of Deviations& CAPAs, Product Complaints and, Vendor Qualification.

Validation/Qualification: Process Validation, Cleaning validation, HVAC System (Clean Rooms), Water System, LAF Units, Incubators, Sterilizers (Steam/Dry Heat), Disinfectant efficacy, Incubators, Area mapping etc.

COMPUTER: MS Office (Word, Excel, Power point)

Professional Experience

Manager –Quality Assurance 06/29/2015 - 12/01/2015 Sovereign Pharma Pvt Ltd. Daman, India

(Approvals: MHRA, WHO GMP)

Responsible for risk management (FMEA), change control, deviation and capa management.

Review of Site Master File.

Associated with handling of External / Internal audits, conducting training and quality management reviews.

Manager –Quality Assurance (Microbiology Lab) 10/01/2014 - 05/30/2015 OM Research Lab, Ahmedabad, India

(Approvals: Indian FDA)

Supervision of Microbiology lab activities.

Reviewing and approving Microbiology test reports.

Instrument / utility qualification.

Manager –Quality Assurance 07/23/2012 - 09/03/2014 Zydus BSV Pvt.Ltd. Ahmedabad, India

(Approvals: USFDA, German FDA, WHO GMP)

Overall responsible for QA activities to ensure that cGMP system are followed and up to date as per applicable regulatory requirements. Planning of departmental budget.

Handling of Media fill, Review of Site Master File, VMP, Annual Product Review, SOPs, BMR, Risk assessment documents (FMEA), Handling of External audit and compliance, Self-inspection.

Planning of validation activities. (HVAC system (Clean room), equipment (Incubator/stability chamber, Area mapping) Water system, Steam sterilizer, Tunnel and other utility systems.

Imparting cGMP training to staff.

Asst.Manager –Quality Assurance 03/19/2010 - 07/19/2012 Concord Biotech Pvt.Ltd Ahmedabad, India

(Approvals: USFDA, German FDA, KFDA, WHO GMP)

Associated with:

Vendor Qualification

Review of change controls, deviation, capa & risk management reports. Page 2 of 3

Preparation of QMS document (Process/ Cleaning Validation protocol / report, Quality Manual & Site Master File, QA SOPs).

Asst.Manager –Quality Assurance 04/19/2008 - 03/16/2010 Biotech Ophthalmic Pvt Ltd. Ahmedabad, India

(Approvals: WHO GMP, ISO 9000)

Reviewing and approving of Master Documents and Batch release.

Review of SMF, Validation Master Plan.

Handling of Market complaints, change controls, deviation and capa.

Handling of Internal and External Audit compliance

Validation and Qualification– IQ, OQ, PQ, FAT of Steam Sterilizer, Dry Heat Sterilizer, Incubators, Filling machine, Vial Washing Machine, Water and HVAC systems. Sr. Executive – Quality Assurance 10/01/2007 - 04/15/2008 Claris Life Sciences Ltd Ahmedabad, India

(Approvals: USFDA,WHO GMP)

Associated With:

Planning and Handling of Aseptic media fill batches, review of media fill protocols & reports.

Responsible for in-process quality assurance activities as “Section In Charge”.

Reviewing and approving of master batch document and Batch release. Executive – Quality Assurance 07/01/2006 – 08/30/2007 Novartis Vaccines & Diagnostics Pvt. Ltd. Ankleshwar, India

(Approvals: WHO GMP, GCC)

Handling of Media fill batches, review of Aseptic process validation report.

Ensure cGMP through in process checks.

Change control & SOP management (EDMS system)

BMR issuance & review and release of the final Batch.

Preparation and Review Summary Protocol of the “Rabipur”batch & coordination with CRI for release of Batch.

Officer – Microbiology Lab 11/04/2004 – 06/19/2006 Sun Pharmaceutical Ltd. Vadodara, India

(Approvals: WHO GMP)

Handling of Microbiological Lab, Performing Microbiological testing (MLT as per USP) of Samples ( Air samples, Water sample, Product samples).

Maintaining Microbial cultures, Handling of external and internal audits. Officer – Microbiology Lab 07/25/2004 – 10/19/2004 Cadila Pharmaceutical Ltd. Ahmedabad, India

(Approvals: WHO GMP)

Handling of Microbiological Lab, Performing Microbiological testing of Samples. (Antibiotic Bio Assay).

Maintaining Microbial cultures.

Sr.Chemist – Vaccine Manufacturing 07/01/20014 – 07/06/2004 Cadila Healthcare Ltd Ahmedabad, India

(Approvals: WHO cGMP)

Involved in Aseptic techniques for following process, Preparation & handling of Seed Virus aseptically.

Preparation & filtration of Bulk product & In process sterility checks of seed virus, bulk product. Media fill run activities.

BMR checking

Assisted Qualification of HVAC system, Water system, sterilizer, DHS, Incubators etc. Page 3 of 3

Audit Experience:-

USFDA, EUGMP(German FDA), KFDA, GCC, WHO

International Customer Audit (Novartis, Astrazeneca, SanofiAventis, Baxter, Teva pharma, Abott,Cipla, Ranbaxy, Mylan, Pfizer, Glaxo, Boehringer ingelheim etc.) Educational Qualifications:-

M.Sc. (Microbiology) Sardar Patel University 2001. B.Sc. (Microbiology) Sardar Patel University 1998. Average Grade : 3.0 (Major Subject)

Personal Profile

Name : Chirag Bhatt

DOB : 05/13/1978

Marital Status : Married

Father's Name : Dr. Pravinchandra K Bhatt

US work Authorization : Yes (Permanent residence)

Social Security Number : Awaited

References:-

will be provided whenever asked for.

Signature : (Chirag Bhatt)

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