Experience

Bristol Laboratories Ltd.

• United Kingdom
• Pharmaceutical Manufacturing
• 300 - 400 Employee

• Microbiology Officer

  • Aug 2019 - Present

  Conduct investigations on OOS occurrences, assess impact of laboratory error and determine disposition Serve as GLP trainer for program staff resulting in reduce OOS occurrences due to technician error Initiate non-conformance investigations to document and track product/manufacturing/laboratory OOS, RCI and CAPA issues Recommend and implement in-process and laboratory improvements for compliance and GMP Participate in the development and execution of study protocols Participate in method validation and method transfer activities Establish and maintain Good Laboratory Practice (GLP) compliant environment Participate in qualification studies (IQ, OQ, PQ) studies on equipment Plan and organize activities of QC laboratory Manage receipt, storage, and disposal of samples Verify adequate cleaning and sanitation of equipment Preparing area and may participate in internal and external quality audits Monitor adequacy of inventory for laboratory operations Adhere to and promote the adherence to all Corporate, Quality and Health and Safety policies and procedures. Interface with other functional groups within and outside of QC Show less



Pfizer

• Events Services
• 1 - 100 Employee

• Senior Executive

  • Mar 2013 - Jan 2019

  Environmental monitoring in Grade A, B, C and D areas, document results any signs of contamination Enumerate and Identify Bacteria isolates to species level using BD Phoenix and Vitek2 Compact systems Sound experience in Endotoxin Testing for Water (WFI, Pure Steam condensate), API, In process samples and Finished products by Gel clot and Kinetic Turbidimetric methods. Labware LIMS - Business Analyst, active participation in the management of Labware in close collaboration with IT team LIMS Administration: define, create and manage static and dynamic data templates in the LIMS (analyses, testing plates layouts, positioning of controls and reagents, user accesses) and support labs Testing of LIMS static data using HP ALM Tool Product Sterility testing by open and closed methods using Isolator. Product Bioburden Testing by direct inoculation and membrane filtration methods. Audits - Involved in audits by USFDA, MHRA, Health Canada, TGA, and WHO Reports - Environmental monitoring and water data reports Provide technical guidance, expertise and leadership to initiatives within the microbiology laboratory. Manages microbiology department initiatives, and influences applicable technologies, policies, programs, and systems management. Schedules and prioritize work for staff and develop training and analyst qualification programs to perform assays under cGMPs Provide technical support to R&D for new product development Prepare in-depth risk assessment for all new product development and provide Microbiology expert summary for Regulatory submission Lead and participate in the development and improvement of processes for existing and new products Attend technical conference for continued development of technical knowledge; and shares knowledge with other employees. Involved in Global Harmonization initiatives like LIMS (Laboratory Information Management System) and Smart QC Show less



Biological E. Limited

• India
• Pharmaceutical Manufacturing
• 700 & Above Employee

• Executive - Microbiology

  • Nov 2009 - Jun 2013

  Assists in developing, writing and updating, laboratory SOP’s and approved procedures Perform instrumentation work Be a point of contact for suppliers for new process development, quality issues and process improvements for assigned projects Assist in provide training microbiology topics including sample collection and analysis Makes and records observations, performs calculations, collects and may assist in preparing data for evaluation. Keeps supervisor informed of work status Perform standardized tests using general laboratory equipment. Performs routine care of designated test equipment and work area Makes and records observations, performs calculations, collects and may assist in preparing data for evaluation Perform microbiological testing of raw materials, work-in-process, and finished product for product approval and release Create and revise forms, work instructions or SOP’s with guidance Provide recommendations and feedback on testing results to management Follow policies and assists in the development of new procedures and/or documents Show less