Summary
Overview
Work History
Education
Skills
Training
Timeline
Generic

Pathik Patel

Clearwater,USA

Summary

Accomplished Project Manager at Belcher Pharmaceuticals Inc. with a proven track record in team leadership that enhances compliance and operational efficiency. Expertise in analytical instrument calibration and method validation has driven significant productivity improvements. Strong problem-solving abilities and a commitment to collaboration foster a motivated work environment, ultimately boosting employee performance. Focused on applying these skills to innovative projects that contribute to organizational success.

Overview

21
21
years of professional experience

Work History

Asst. Manager

Belcher Pharmaceuticals LLC
, USA
01.2022 - Current
  • Handling Lab incident, investigation, deviation, CAPA, interim report and Vendor non-conformance of QC Labs for Raw materials, Finished product, In-process samples and Stability samples
  • Direct contact with the new vendor (customer) for discussion about specifications, methods, method development and method transfer, validation protocols, and validation reports. Provide required data or documentation for the in-house QC team or vendor.
  • Support to Lab Manager / Director by doing hypothesis on OOS or OOT results
  • Review cleaning validation protocol and report. Finalize the method for any cleaning validation.
  • Handling of contract lab method developments, method validations, method transfer, and OOS or OOT results.
  • Handling of troubleshooting on the hardware and software sides for major lab equipment.
  • Responsible for raw materials, packaging materials, finished products, in-process samples, and stability samples receiving to release activities.
  • Responsible for all raw materials, packaging materials, finished products, in-process samples, and stability samples specification preparation and revision as per current USP/NF.
  • Operates general analytical instruments during testing with Raw material, In-Process, Finished Product and Stability Testing
  • Responsible of all wet chemistry analysis related instrument’s Standard Operational Procedure preparation as per general chapters of USP / NF and manufacturer’s operational procedure
  • Troubleshooting for Karl Fischer, FTIR, UV, HPLC, Dissolution, Tap density taster, ICP-MS, Potentiometric titrator etc
  • Responsible for receiving results and reports from contract laboratories
  • Responsible for taking care of controlled substance of Raw materials
  • Write SOP’s and change control forms for operation of lab instruments
  • Developing methods for justification and validation according to FDA (USP), & EP requirements
  • Responsible for general SOP preparation and revision
  • Responsible for Raw materials and Packaging materials testing and documentation as per cGMP and company SOP
  • Responsible for testing and handling of working standard preparation
  • Independently set-up, maintains, operate and perform routine and non-routine maintenance on general equipment, including problem identification and resolution
  • Perform various analytical tests on stability samples
  • Maintain, troubleshoot & calibrate various analytical instruments

Group Leader

Belcher Pharmaceuticals Inc.
, USA
10.2016 - 12.2021
  • Support the Lab Manager by doing a hypothesis on OOS or OOT results.
  • Handling of contract lab method developments, method validations, and OOS or OOT results.
  • Method development for the cleaning procedure and creating the final method.
  • Preparation for the cleaning validation protocol and report.
  • Responsible for raw materials, packaging materials, finished products, in-process samples, and stability samples receiving to release activities.
  • Responsible for all raw materials, packaging materials, finished products, in-process samples, and stability samples specification preparation and revision as per current USP/NF.
  • Operates general analytical instruments during testing with raw material, in-process, finished product, and stability testing.
  • Responsible for all wet analysis-related instrument Standard Operating Procedure preparation, as per the general chapters of USP/NF and the manufacturer’s operational procedure.
  • Responsible for the validation and calibration of FT/IR spectrophotometers.
  • Responsible for the calibration of the UV spectrophotometer.
  • Responsible for Karl Fischer (Metrohm) standardization and analysis for solid and liquid materials, finished products, in-process, and stability samples.
  • Responsible for receiving results and reports from contract laboratories.
  • Responsible for taking care of controlled raw materials.
  • Write SOPs and change control forms for the operation of lab instruments.
  • Developing methods for justification and validation according to FDA (USP) and EP requirements.
  • Responsible for general SOP preparation and revision.
  • Responsible for raw materials and packaging materials testing and documentation as per cGMP and company SOP.
  • Responsible for testing and handling of working standard preparation.
  • Independently set up, maintain, operate, and perform routine and non-routine maintenance on general equipment, including problem identification and resolution.

Sr. Chemist

Belcher Pharmaceuticals Inc.
, USA
01.2012 - 10.2016
  • Responsible for Raw materials and Packaging materials receiving to release procedure
  • Responsible for all Raw materials and Packaging materials Specification preparation and revision as per current USP / NF
  • Responsible for all Raw materials and Packaging materials Standard Test Procedure preparation and revision as per current USP / NF
  • Operates general analytical instruments during testing with raw material, In-Process, Finish Product and Stability Testing
  • Responsible of all wet analysis related instrument’s Standard Operational Procedure preparation as per general chapters of USP / NF and manufacturer’s operational procedure
  • Responsible for validation and calibration of FT / IR spectrophotometer (Jasco 4100)
  • Responsible for calibration of UV spectrophotometer (Jasco 6300)
  • Responsible for Karl Fischer (Metrohm) standardization and analysis for solid and liquid materials, finish product, in-process and stability sample
  • Responsible for receiving results and reports from contract laboratories
  • Responsible for taking care of controlled Raw materials
  • Write SOP’s and change control forms for operation of lab instruments
  • Develop methods for justification and validation according to FDA (USP), & EP requirements
  • Responsible for general SOP preparation and revision
  • Responsible for Raw materials and Packaging materials testing and documentation as per cGMP and company SOP
  • Responsible for testing and handling of working standard preparation
  • Independently set-up, maintains, operate and perform routine and non-routine maintenance on general equipment, including problem identification and resolution
  • Perform various analytical tests on stability samples
  • Maintain, troubleshoot & calibrate various analytical instruments

Chemist

Belcher Pharmaceuticals Inc.
, USA
11.2007 - 12.2011
  • Responsible for Raw materials and Packaging materials receiving to release procedure
  • Operates general analytical instruments during testing with raw material, In-Process, Finish Product and Stability Testing
  • Responsible of all Raw materials and Packaging materials Specification preparation and revision as per current USP / NF
  • Responsible for all Raw materials and Packaging materials Standard Test Procedure preparation and revision as per current USP / NF
  • Responsible of all wet analysis related instrument’s Standard Operational Procedure preparation as per general chapters of USP / NF and manufacturer’s operational procedure
  • Responsible for validation and calibration of FT / IR spectrophotometer (Jasco 4100)
  • Responsible for calibration of UV spectrophotometer (Jasco 6300)
  • Responsible for Karl Fischer (Metrohm) standardization and analysis for solid and liquid materials, finish product, in-process and stability sample
  • Responsible for receiving results and reports from contract laboratories
  • Responsible for taking care of controlled Raw materials
  • Responsible for general SOP preparation and revision
  • Responsible for Raw materials and Packaging materials testing and documentation as per cGMP and company SOP
  • Responsible for testing and handling of working standard preparation
  • Independently set-up, maintains, operate and perform routine and non-routine maintenance on general equipment, including problem identification and resolution
  • Perform various analytical tests on stability samples
  • Maintain, troubleshoot & calibrate various analytical instruments

Quality Control Officer grade II

Sun Pharmaceuticals Inc.
Halol, India
01.2004 - 07.2007
  • To perform various analytical tests to ensure the quality of Sun Pharmaceuticals products
  • Performed Calibration and analysis of raw materials and packing materials on UV spectrophotometer
  • Performed FT/IR (Shimadzu) and NIR calibration, validation and analysis of Raw materials and Packing materials
  • Performed Malvern Particle sizer calibration, wet method and dry method analysis
  • Responsible for Raw materials and Packing materials sampling as per current USP / NF
  • Performed auto titration (Mettler Toledo DL 31) calibration, method development and Raw materials analysis
  • Performed and Calibrated Refractometer and Polarimeter analysis
  • Authorized and reviewed SOP’s, methods and change control forms on the operation of instruments and developed new methods, giving justification for testing within the scope of regulatory requirements
  • Performed and calibrated of Karl Fischer titration and coulometer titration to determine water content for Raw materials
  • Performed HPLC (Water and Shimadzu) analysis for Raw materials
  • Responsible for all Raw materials and Packaging materials Specification preparation and revision as per current USP, EP and IP
  • Responsible for all Raw materials and Packaging materials Standard Test Procedure preparation and revision as per current USP, EP and IP
  • Performed and calibrated Brookfield viscometer, disintegration tester, tapped density meter, sieve shaker, oven, muffle furnace, melting point and pH meter
  • Maintain, troubleshoot & calibrate various analytical instruments
  • Support actively in internal QA and USFDA audit

Chemist

Elysium Pharmaceuticals Inc.
Dabhasa, India
08.2003 - 01.2004
  • Performed Raw materials wet analysis and Calibration for UV spectrophotometer, FT-IR, Karl Fischer for Water content, Sieve shaker Particle size, Polarimeter, Refractometer, Swab analysis, HPLC, bulk density meter, Auto Titration instruments
  • Responsible for Raw materials sampling

Education

Master of Business Administration -

Schiller international university
USA
12.2009

Master of Science -

Gujarat University
Gujarat, India
05.2003

Bachelor of Science -

Gujarat University
Gujarat, India
04.2001

Skills

  • Team collaboration
  • Employee engagement
  • Team motivation
  • Staff training and development
  • Workplace safety compliance
  • Project management
  • Workload management
  • Employee performance evaluation
  • Problem-solving
  • Compliance
  • Contract management

Training

Determination of water content by automated titration, Metrohm, 06/01/09

Timeline

Asst. Manager

Belcher Pharmaceuticals LLC
01.2022 - Current

Group Leader

Belcher Pharmaceuticals Inc.
10.2016 - 12.2021

Sr. Chemist

Belcher Pharmaceuticals Inc.
01.2012 - 10.2016

Chemist

Belcher Pharmaceuticals Inc.
11.2007 - 12.2011

Quality Control Officer grade II

Sun Pharmaceuticals Inc.
01.2004 - 07.2007

Chemist

Elysium Pharmaceuticals Inc.
08.2003 - 01.2004

Master of Business Administration -

Schiller international university

Master of Science -

Gujarat University

Bachelor of Science -

Gujarat University

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Pathik Patel