Ankur Patel (Roy) MS, MBA

Experience

• 

  Ipca Laboratories Limited

  Apr 2014 - Aug 2019

  QA Executive

  •Role in Product Failure Investigation, Compilation of investigation reports and related documents for their closure with prescribed documentation.•Root cause analysis of Quality related issues and Implementation of CAPA through proper documentation.•Batch record review and final Release of batches for dispatch.•Investigation of market complaints, preparing the response for the complainant, and closure of the Market complaint through proper documentation.•Investigation of Incidence and implementation of the corrective actions.•Evaluation and Closure of Deviation, Change Control, and OOS with proper documentation.•Audit of Contract Manufacturers.•Audit of Vendors for Packaging material, Raw Material, and Finished Goods distributors.•Imparting Self Inspection/Internal Audits and assuring implementation of the required change for improvement in the Quality system.•Preparing training calendar and matrix after assessing individual’s training needs and maintaining all the training records.•Ensuring periodic validation and Re-Validation related to process and equipment/Instruments whenever required.•Prepared and review Batch Production Records (BPR) And preparation of Certificate of Analysis (COA).•Coordinating with R&D and QC Lab for Stability and Holding Time Study related issues.•Implements strict auditing protocols to ensure that all activities and processes across the manufacturing, testing, and distribution facilities comply with cGMP/cGDP.•Undertakes investigations of deviation and non-compliance; ensures all CAPA are identified and implemented within a given time frame; execute audits and provides approval of completed batch documentation ensuring compliance to GMP and applicable data requirements.•Collaborates with preparing Standard Operating Procedures, Validation Protocols, and reports.•Maintains professional knowledge and regulatory compliance by ensuring awareness of pertinent changes and implementing the same as appropriate. Show less

• 

  Avaco Research & Development LLP

  Oct 2019 - Mar 2022

  Analytical Development Lab In-charge

  • Perform physical, chemical, & instrumental analysis of active pharmaceutical ingredients & finished pharmaceutical products to support clients´ needs using various techniques – HPLC, Uv-Vis, GC (GC-HS), FT-IR, Karl Fisher, and Potentiometric Titration.• Test and analyze raw materials, packing materials, and finished products, in line with standard operating procedures.• Create and manage specifications of raw materials and finished products to ensure compliance with quality standards.• Prepare reagents and test solutions for day-to-day use in the laboratory.• Sets up and operates chemical production equipment under laboratory conditions to test• methods and perform chemical reactions for product development.• Perform analysis on finished products to determine chemical entity using UV-Vis spectroscopy and IR spectroscopy• Perform calibration of laboratory equipment on time and keeps records of it.• Prepare documents like SOPs, new specifications, method of analysis (MOA) for raw materials,• in-process analysis, finished products.• Responsible for keeping chemical stocks, disposing of used chemicals in-line with laboratory policies and procedures, and keeping updated records using material management standard procedures.• Maintain all documentation and update on data system to be used for future chemical products.• Prepare and analyze samples in a laboratory environment according to standard procedures to develop new products and techniques.• Handling of Documentation related Experiments and Testing of developing drugs.• Handling legal documentation. Show less

• 

  Sigma - Independent Together

  May 2022 - Oct 2023

  • Ensuring that all goods that are loaded or unloaded match the relevant paperwork.• Reporting any damaged or missing goods to Warehouse Managers or Supervisors.• Keeping the warehouse environment clean and tidy and maintaining equipment.• Following workplace health and safety rules when handling goods.• Ensuring efficient operations by adhering to operational procedures, rules, and schedules.• Assisting with warehouse inventory controls, which typically involves using a hand-held scanner.• Store all products following FEFO (first expiry first out) system.• Ensure that the shipping areas (by destination) are identified; store goods on shelves or palettes (as necessary), in a clean, tidy, and easily accessible manner.• Pack (appropriately for the mode of transport chosen), weigh, and label freight (destination, number of shipping units, waybill number, weight, and mode of transport), and assign a shipping number to each package, following the instructions of the line manager.• Ensure that all necessary information is correctly and fully recorded on the stock cards: batch number, expiry date, date of receipt or delivery, stock balance (incoming/outgoing), receipt, and delivery document reference numbers.• Inform the line manager when the stock of goods is nearing the minimum or maximum threshold, and regularly provide the line manager with a list of the items with expiry dates within the next six months.• Monitor the temperature of the central pharma warehouse including freezers and refrigerators twice a day and ensure that products requiring cold chain are always stored at a suitable temperature (between +2°C and +8°C).• Immediately inform the line manager of any problems arising in the course of the work, particularly regarding damage, loss, attempted break-ins, or theft in the warehouse. Show less • Ensuring that all goods that are loaded or unloaded match the relevant paperwork.• Reporting any damaged or missing goods to Warehouse Managers or Supervisors.• Keeping the warehouse environment clean and tidy and maintaining equipment.• Following workplace health and safety rules when handling goods.• Ensuring efficient operations by adhering to operational procedures, rules, and schedules.• Assisting with warehouse inventory controls, which typically involves using a hand-held scanner.• Store all products following FEFO (first expiry first out) system.• Ensure that the shipping areas (by destination) are identified; store goods on shelves or palettes (as necessary), in a clean, tidy, and easily accessible manner.• Pack (appropriately for the mode of transport chosen), weigh, and label freight (destination, number of shipping units, waybill number, weight, and mode of transport), and assign a shipping number to each package, following the instructions of the line manager.• Ensure that all necessary information is correctly and fully recorded on the stock cards: batch number, expiry date, date of receipt or delivery, stock balance (incoming/outgoing), receipt, and delivery document reference numbers.• Inform the line manager when the stock of goods is nearing the minimum or maximum threshold, and regularly provide the line manager with a list of the items with expiry dates within the next six months.• Monitor the temperature of the central pharma warehouse including freezers and refrigerators twice a day and ensure that products requiring cold chain are always stored at a suitable temperature (between +2°C and +8°C).• Immediately inform the line manager of any problems arising in the course of the work, particularly regarding damage, loss, attempted break-ins, or theft in the warehouse. Show less

  • Warehouse Operative

    Aug 2023 - Oct 2023

  • Warehouse Operative

    May 2022 - Jul 2023
• 

  Kedrion Biopharma

  Oct 2023 - now

  Production Technician

  •Carry out through development, specific processes within downstream purification and formulation in compliance with cGMP, product licenses, H&S standards, and KPI’s.•As the Process Technician of a designated process, to operate processes such as Chromatography, Centrifugation or ultrafiltration, and other fully automated processes, for which I develop a full operational understanding. •Actively support an environment of continuous improvement ensuring that all quality and productivity targets are achieved through the optimum use of resources in a safe environment. To use effective communication skills with all team members to ensure completion of the Production Manufacturing and filling plans. •Analyse issues and effectively problem-solve, in support of the Team Leader.•Develop a full understanding of specific environments, process flows, and equipment operation. •Develop an understanding of the mechanical nature of specific equipment and perform minor maintenance tasks such as assembly for use and periodic hygienic change of components such as sample septums. •Have a basic understanding of utilities Including – HVAC operations, WFI, Purified Water and demineralised water, coolant systems, and the Ethanol plant.•Manufacture products in compliance with approved procedures and in accordance with agreed production programs.•Help maintain local and business KPI standards and requirements.•Help co-ordinate the activities of the section, liaise with other sections as necessary, and help organise the daily work operations as required.•Ensure and maintain high standards of GMP and H&S.•Develop skills that will enable reviews of SOP’s, BPR’s and related documentation as required by the Team Leader.•Conduct specific investigations.•Inform the Team Leader of concerns related to the maintenance of working and environmental standards and help ensure the working environment is maintained to the required specification. Show less