Mohammad Rongin

Experience

• 

  Opsonin Pharma Ltd

  Oct 2005 - Nov 2007

  Officer

  Responsible for analyst of QC laboratory

• 

  Square Pharmaceuticals Limited

  Dec 2007 - Mar 2016

  • Involved with US-FDA project of raw materials/product testing, documents review & release.• Involved with source sample analysis, vendor dealings & vendor approval procedure. • Responsible to prepare the specification, analytical testing method, standard operating procedure, equipment operation procedure & equipment calibration procedure. • Handle the SAP system (QM module)• Involved with Laboratory data integrity, CDS system• Audit management activities. • Involved with OOS, QIR, LIR, deviation investigation • Involved the API quality review, Quality rating activities of all raw materials • Involved on Gas qualification activities. • Handling the IQ, OQ of Lab equipment. • Lab equipment URS preparation, Comparative study & requisition related activities • Release the raw material & packaging material in-absence of Manager, QC• To review the documents of bulk products in absence of Manager, QC • To check the calibration documents, working standard documents in absence of Manager, QC• Reporting for responsibilities to Manager, Quality Control• In absence of Manager, QC responsible to release the all starting materials, approval the all quality documents. Show less

  • Senior Executive (Grade M-12)

    Jan 2016 - Mar 2016

  • Senior Executive (Grade-M13)

    Jan 2013 - Dec 2015

  • Executive (Grade-M14)

    Jan 2010 - Dec 2012

  • Executive (Grade-M15)

    Dec 2007 - Dec 2009
• 

  Opsonin Pharma Ltd

  Mar 2016 - Sept 2018

  Deputy Manager

  Manage & coordinate activities of Quality Control Staff to support company goals and objective, including direct supervision of all Quality Control personnel and managing a team for Laboratory testing and documentation and ensure Laboratory compliance.Lead and drive all testing, documentation for assigned projects/products. Make quality control decisions, balancing risks and benefits.Assist to support the all Laboratory Instrument operation, troubleshooting & calibration worksProvided administrative and logistic support for the activities conducted by the Quality Control Department. Ensured all regulatory documentation was compliant with Standard Operating Procedures (SOP’s) for product safety, efficacy and purity. Show less

• 

  The ACME Laboratories Ltd.

  Sept 2018 - now

  Manage & coordinate activities of Quality Control Staff to support company goals and objective,including direct supervision of all Quality Control personnel and managing a team for Laboratory testing and documentation and ensure Laboratory compliance. Assisted in the coordination and organization of multiple facets of regulatory procedures and operations within the Quality Control activities and across the company's product portfolio. Lead and drive all testing, documentation, regulatory activities (planning, preparing, authoring, reviewing, coordinating etc.) for assigned projects/products. Make quality control decisions, balancing risks and benefits.Compiled documentation and maintained laboratory data integrity in compliance with regulatory requirements. Provided administrative and logistic support for the activities conducted by the Quality Control Department. Ensured all regulatory documentation was compliant with Standard Operating Procedures (SOP’s) for product safety, efficacy and purity. Laboratory Compliance Management till approval of the product in coordination with Cross functional teams. Show less

  • Sr. Manager-I, Quality Control

    Jan 2023 - now

  • Sr. Manager-II, Quality Control

    Mar 2019 - Dec 2022

  • Manager, Quality Control

    Sept 2018 - Mar 2019