Experience

Vivariant Laboratories

• Canada
• Biotechnology Research
• 1 - 100 Employee

• Quality Assurance Manager and Head of the laboratory

  • Dec 2019 - Present

  - Design and implement comprehensive quality management system complaint with GMP and ISO standards. - Establish, develop and implement Document Control in compliance as per current GMP and ISO standards. - Develop and implement Plan Deviation, Non-conformance, OOS investigation and CAPA implementation program. - Establish, manage, and execute internal audits along with necessary action implementation. - Handling customers for technical, quality, and business-related information for multiple industry regulatory guidance such as FDA, Health Canada and ISO. - Participation in business development with client interaction and cost management. - Review and Approve quality control processes and QA activities. - Review and approve validation protocols, reports, SOP’s, and other quality documentation. - Develop and implement calibration, and preventive maintenance program for various equipment. - Establish and manage training program for new and existing employees. - Hire and manage all department managers and quality department employees. - Assist in procurement of equipment to set up analytical chemistry department for multiple testing. - Review and Approval of method validation for various analytical testing procedures. - Review and Approve raw data for various analysis using ICPMS, HPLC-UV, LC-MSMS, GC-FID and MS etc., ID test and quantification test. - Coordinate, manage and lead all external client and regulatory audits. - Vendor qualification and management for procurement of various equipment and materials. - Create and implement Management review program. - Establish Performance Evaluation program and Personnel development program for employees. Show less

• Chief Microbiologist

  • Sep 2018 - Oct 2019

  - Designing floor plan for the laboratory operations from ground planning. - Managing vendors and procuring equipment for the initial laboratory set up required for all Microbiological laboratory operations. - Preparing and designing a qualification program (IQ/OQ/PQ) for various equipment such as fridge, freezers, incubators, stability chambers etc. - Assisting in regulatory documentation for analytical testing license using CTLS application and ISO/IEC 17025 certification. - Writing SOP and working instructions for quality control processes and microbiological analysis. - Hiring and training new employees and assisting existing employees with continuous refresher training program. - Review and approval of analytical reports, logbooks, and records. - Participate in business development and establishing client relation. - Create and implement environmental bio-burden management plan. Show less



Eurofins Experchem

• Quality Assurance

  • Sep 2017 - Aug 2018

  - Investigation of Out of Specification results for cannabis, pharmaceutical, cosmetic and natural health products.- Sterility program set up for quality control and validation activities, environmental monitoring program, and coordinate investigations.- Assist in Sterility Room set up and validate the cleanroom for GMP accreditation.- Handling client's queries for technical assistance and guiding them appropriately with current compliance.- Assist in method transfer, SOP writing, and other quality documents.-Review and approve test reports for cannabis, pharmaceutical and natural health products.-Approve and coordinate different quality control processes for laboratory activities.- Train and coordinate new employees on equipment, methods and techniques. Show less

• Senior Microbiologist

  • Jan 2015 - Aug 2017

  - Managing high volume of pharmaceutical products, cosmetic products, medical cannabis and Natural Health products.- Writing protocols for Environmental Monitoring for client manufacturing site and assistance in execution of cleaning and sanitation process in different areas at the manufacturing site.- Sterility samples testing such as injectables, medical devices and other sterile products.- Cleaning and maintaining of Grade A rooms along with environmental monitoring.- Method validation, performing suitability and particulate testing for sterile injectables and other pharmaceutical products.- Antibiotic assays development and testing as per USP compliance and other client methods. Show less



Experchem lab Inc

• Microbiologist Analyst II

  • Jul 2012 - Dec 2014

  - Perform environmental monitoring and laboratory water system testing. - Maintenance and transfer of various types of Biosafety Level II pathogens. - Microbial Limit testing for pharmaceuticals and natural health products. - Identification of different types of micro organisms using different techniques such as Analytical Profile Index (API), BioLog etc. - Microbiology laboratory representative for Joint Health and Safety Committee (JHSC). - Perform environmental monitoring and laboratory water system testing. - Maintenance and transfer of various types of Biosafety Level II pathogens. - Microbial Limit testing for pharmaceuticals and natural health products. - Identification of different types of micro organisms using different techniques such as Analytical Profile Index (API), BioLog etc. - Microbiology laboratory representative for Joint Health and Safety Committee (JHSC).

• Microbiologist analyst I

  • Sep 2010 - Dec 2011

  - Media preparation and decontamination of waste. - Cleaning and maintenance of glassware. - Environmental Monitoring and water testing for the Micro department. - Growth promotion test and ATCC culture transfer and maintenance for lab use. - Microbial limit testing for Non-sterile pharmaceutical products. - Media preparation and decontamination of waste. - Cleaning and maintenance of glassware. - Environmental Monitoring and water testing for the Micro department. - Growth promotion test and ATCC culture transfer and maintenance for lab use. - Microbial limit testing for Non-sterile pharmaceutical products.



Global institute of biotechnology

• India
• Biotechnology Research

• Research assitant

  • Jun 2009 - Dec 2009

  Isolation of pathogenic gene from the microbes found in waste water system. Isolation of pathogenic gene from the microbes found in waste water system.