Quality Manufacturing
Resume:
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
Trainings
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
Education
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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