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Quality Manufacturing

Dublin, Ohio, United States
June 07, 2017

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Dublin, OH-*****


Bhavesh Patel

Career Summary

More than 8 years of experience following cGMP, GLP, GDP, FDA and ICH guidelines. Technical expertise in reviewing cleaning and process validation; experience of handling technology transfer, preparing annual product quality reports, conducting internal audits for cGMP compliance and vendor qualification activity for contract manufacturing. Reviewing and approving SOPs, protocols, technical documents and stability data and reports for cGMP compliance. Knowledge of industry specific application i.e. SAP and TrackWise; effective communicator with written and oral communication skill; able to troubleshoot, prioritize and solve problems in a timely manner and interact with individuals on all levels; experience of supervising a QA team and coordinating with the different functional group to perform day to day activities.

Work Experience

PharmaForce Inc. (Columbus, OH)

QA Technical Services Specialist Since Dec. 2015

Review proposed changes and justifications to validation, qualification, and calibration SOPs and protocols to ensure compliance with FDA requirements

Review validation of computerized system and relevant change controls

Review laboratory testing data, various validation/verification documentation, technology transfer documents, maintenance, and metrology documentation to confirm accuracy and completion of work according to pharmaceutical industry standards

Evaluate audit findings and recommend improvements for corrective action

Initiate quality assurance activities on cross functional teams

Provide support for the completion of quality system exceptional documents and investigation

Review of aseptic environmental monitoring and air filtration qualification documents

QA Data/Document Review Associates Sept.2014-Dec.2015

Reviewed laboratory data for raw material, packing material, finished product and stability testing data for its correctness and compliance with approved specifications and USP requirements

Reviewed environmental and personnel monitoring data as per aseptic manufacturing standards

Reviewed proposed changes to laboratory methods and specifications ensuring compliance with USP and FDA guideline requirements

Various validation documentation and cGMP qualified reports including process validation, cleaning validation, method validation, technology transfer documentation reviewed for FDA guideline compliance

Compiled and evaluated annual product review of all marketed product

Responsible for in-process testing and daily water testing data review

US Pharma Lab Inc. (North Brunswick, NJ) Jul.2014-Sept.2014

QA/QC Coordinator

Prepared quality documents that included site master file and validation master plan for EMA submission

Co-ordination with QC lab for day to day testing and finish product release activities

Finished product sampling and pre-dispatch inspection before the shipment

provided necessary technical information, documents to carry out day to day QA activities i.e. issuance of BRs. BPRs and BCRs to production personnel

Reviewed raw material and finished product specification with USP requirements

Torrent Pharmaceuticals Ltd. (Ahmedabad, India) Jan.2012-Jan.2014

Executive QA

Performed equipment and facility qualification activities as per cGMP & schedule-M requirements

Responsible for assuring facility compliance with cGMP, GLP, GDP and FDA guidelines

Reviewed and created SOPs, validation master plan, qualification protocols, summary reports, documented risk management using HAZOP technique

Assisted in conducting and reporting external audits of suppliers and contract facilities as well as internal quality systems and assured compliance with applicable regulatory requirements and procedural requirements and expectations

Compilation and evaluation of annual product quality review of marketed products. Analysis of data to identify the area of improvement. Establishment of QPI's and implement track and trending activities to promote and monitor improvements

Handled technology transfer documents

Responsible for handling of change control, OOS & deviation activities

Performed process and cleaning validation activities

Zydus Cadila Ltd. (Ahmedabad, India) Sep.2010-Jan.2012

Executive QA

To assure facility compliance with cGMP, EMA requirements and ICH guidelines

Lead QA team and handled scheduling and allocating shift and day to day work activity

Validation: equipment, process, cleaning, IQ, OQ, PQ, and CIP

Commissioning of critical manufacturing and facility systems in pharmaceutical environment

Revised and created SOPs, CAPA, URS/FRS, validation master plans, qualification protocols, summary reports and documented risk management using HAZOP technique

Overseeing all facility equipment is scheduled and completed as per SOPs.

Responsible for coordination and record keeping of all quality documentation as per provided record retention program

Active participation and contribution in plant approval/inspection by various domestic and international regulatory bodies

Participated in training for various levels of gowning for manufacturing in clean rooms and SOPs for manufacturing

Handled batch release and distribution activities

Alembic Ltd. (Vadodara, India) Jun.2006-Jul2007

Executive QA

Review of completed BMRs. BPRs and BCRs for completeness of all data entries and analytical raw data

Performed day to day QA operation activities

Handling and inspection of retain samples

Issuance of BMRs, BPRs & BCRs

Inspected finished product packing activities and performed sampling

Claris Lifesciences Ltd. (Ahmedabad, India) Aug.2005-Jun2006

Officer CQA

Conducted vendor evaluation and vendor assessment for contract manufacturing

Performed pre-dispatch shipping inspection at contract manufacturing

Prepared annual product quality report

Handled technology transfer documents for contract manufacturing sites

Involvement in preparing and reviewing contract manufacturing agreements

Ishan Dyes and Chemicals Ltd. (Ahmedabad, India) May.2004-Aug.2005

QC Chemist

Handled analytical instrument i.e. HPLC, GC, KF auto-titrator, IR, pH meter, melting points apparatus

Prepared SOPs and testing specifications

Performed raw material and finished product sampling and testing


Regulatory Education for Industry (REdI) Spring Conference 2017

Regulatory Education for Industry (REdI) Fall 2016 Conference

Pharmaceutical Quality Symposium 2016 organized by CDER

CDER Microbiology Issues: A Deeper Drive

6-weeks internship at Alembic Limited, Baroda

Computer Skills

Strong command of MS Office (word, excel, power point, access) and other window applications

Basic knowledge of SQL

worked with QMS software i.e. SAP TrackWise

Project Work

Study of adsorption phenomena of Chromium(III); using different natural absorbent and effect of physical parameters i.e. temperature, pH and particle size distribution


American Institute of Pharmaceutical Technology, NJ USA

Post Graduate Diploma in Clinical Research Associates, certified in 2008

SP University, V V Nagar, India

MS in Industrial Chemistry graduated 2004

Gujarat University, Ahmedabad India

BS in Chemistry graduated 2002

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