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Nikul Patel is a seasoned quality assurance professional with 11+ years of experience in the pharmaceutical industry, possessing expertise in regulatory affairs, project management, and clinical trials. He holds a Master's degree in Health/Health Care Administration/Management from Fairleigh Dickinson University and a Bachelor of Pharmacy from Karnatak College of Pharmacy.

Credentials

  • ASQ Certified Quality Improvement Associate
    ASQ - World Headquarters
    Oct, 2022
    - Apr, 2026

Experience

  • Prime Health Ltd.
    • Maple Ridge, British Columbia, Canada
    • QC and PRODUCTION coordinator
      • Jun 2022 - Apr 2023
      • Maple Ridge, British Columbia, Canada

      • Monitor all production activities like dispensing, blending, coating, and packaging.• Perform in process testing like friability, hardness, and disintegration test.• Review and release BMR for next stage.• Perform investigation into out-of-specification results.• Sample tracking and documentation.• Write SOPs and review and approved it with QA manager.• Successfully faced Korean audit.

  • J & L BEEF LTD
    • Surrey, British Columbia, Canada
    • Quality Assurance Quality Control technician
      • Apr 2018 - Jul 2020
      • Surrey, British Columbia, Canada

      • Monitor Production area, Packaging, storage, and shipping facilities for conform-ance of company sanitation and safety standards• Conduct Micro test for retained sample at the end of the shelf life and food con-tact surface swabs test.• Write Incidence report and Apply changes if required.• Based on any discrepancy in the test results, applies CAPA.• Recommends modifications of existing quality or production standards to achieve optimum quality within limits of production capacity• Complete documentation provided by HACCP program on daily basis and in real time• Follows Laboratory safety policies, company policies, procedures, and standards for safety (GMP and HACCP)• Perform GMP & Good Hygiene practice Audit weekly or periodically• Perform preoperational checks daily and give line clearance for production• Inspection of returned products, metal detectable and Exterior and Interior Building.

  • Zydus Group
    • Ahmedabad Area, India
    • Quality Assurance Officer
      • May 2013 - Sep 2015
      • Ahmedabad Area, India

      • Process knowledge of overall batch manufacturing record Review and Release for next production process.• Apply CAPA, change control, Deviation when needed.• Review and Approved SOPs.• Update all QA management activities in QMS.• Conduct in process test including friability, Hardness check, Disintegration test.• Successfully faced and cleared USFDA, EU, ANVISA, MOH Audit.• Conduct Internal QA audit in different production departments.• Monitoring in process production of tablets and pellets, check in process BMR, humidity and temperature in production areas and in quarantine area.• Generate, process and complete Certificate of Analysis (C of A), Certificate of Manufacturing (C of M) and Certificate of Packaging (C of P).• Provide GMP training to all production staff on weekly basis.• Review labeling on all quarantined products and updating in the computer system (SAP).• Perform other duties as assigned.

  • Astra Lifecare (India) Pvt. Ltd.
    • Ahmedabad, Gujarat, India
    • Production Officer
      • Jan 2011 - May 2013
      • Ahmedabad, Gujarat, India

      • Worked in Granulation, blending, Compression and coating department.• Give Proper directions about products to machine operators including proper in-gredients, parameters, process time for each step.• Updating all productions documents including BMR, SOPs, temperature, and hu-midity logbooks.• Giving proper training and instructions to all related staff about cGMP, SOPs on daily base.• Review and maintain all documentation related production.• Update and write new SOPs for production department.• Successfully faced WHO, UGANDA (NDA), KENYA, TANZANIA, and CONGO audit.• Preparing monthly production planning and tracing daily production outputs.• Reporting daily activities to General manager.

Education

  • 2015 - 2017
    Fairleigh Dickinson University
    Master administration of science, Health/Health Care Administration/Management
  • 2006 - 2010
    karnatak collage of pharmacy
    Bachelor of Pharmacy (B.Pharm.), Medicinal and Pharmaceutical Chemistry

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