Mahbub Mawla

Experience

• 

  RAK Pharmaceuticals Pvt. limited

  Sept 2014 - Aug 2015

  Deputy Manager Quality Control
• 

  Julphar

  Sept 2015 - Apr 2018

  Quality Control Manager
• 

  Jayson Pharmaceuticals Ltd.

  Jun 2018 - now

  1) Develop and/or implement the department’s strateg to ensure it meets the regulatory requirements, business requirements, as well as ensuring the departmental performance through efficient team building and continual improvement being a key part of ultimate goal to achieve company’s growth and success. 2) Work with the Quality Manual with quality policies, Site Master File, Site Validation Master reports by collecting, analyzing, summarizing information, trends upon review and in line with regulatory guidelines. 3) Root cause analysis with proper investigations, gap analysis, to find out , complaints, out of specification, Microbiology data deviation, discrepancies/ errors, other failures or adverse events. 4) Ensure and implement updated regulatorypharmacopeial requirements to comply GMP and to meet validation, Quality Control, Microbiology and other requirements as recommended. 5) Conduct self-inspection & vendor/suppliers audit program is in place as per schedule or as required. Show less 1) Follow systems and procedures outlined in the company manuals. Ensure Company policies & procedures.2) Comply all systems with GMP ,QMS , GLP , safety requirements3) Manage and monitor the implementation of GLP throughout the Quality control4) Conduct validation activities.(Performance Qualification for Concurrent, Prospective & Retrospective validation) for processes, products, facilities & equipment and cleaning validation .5) Approval or rejection of raw materials, packaging materials, bulk & finished products of OSD, LCO & Injectable Dept. 6) Ensure periodic calibration of QC equipment 7) Ensure chemical studies for process validation ,analytical method validation ,cleaning validation .8) Ensure stability studies for accelerated real time ,on -going samples 9) Ensure availability of updated specifications ,test methods for raw materials ,packaging materials ,intermediate ,bulk & finished products.10) Handling of non-conformities, OOS (Out of specification), customer complaints and recalls & Review of batch records.11) Maintain proper documentation system during all stages of QC work.12) Maintain and develop the systems and procedures within the company's Quality System to ensure compliance with Marketing Authorizations and regulatory requirements.13) Approve Microbial limit test, Bacterial Endotoxins test (LAL), Sterility test, Environmental monitoring, GPT, Bioassay and others routine work.14) Responsibility of overall analytical wing of R&D and Stability study program15) To maintain inventory, proper storage and order for procurement of analytical standards, chemicals, reagents, glass apparatus and laboratory equipment. Show less

  • Senior Quality Control Manager

    Jul 2024 - now

  • Quality Control Manager including Microbiology and Analytical wing of R&D Dept.

    Jun 2018 - Jun 2024