Mohammad Hassan, Ph.D.

Experience

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  T3A

  Jan 2007 - May 2017

  Manage the QC Microbiology laboratory for stability testing, the testing of raw materials, in-process materials, and finished products so that they are performed in a timely and compliant manner based on business need. Ensures the integrity and quality of data generated and that analysts are trained and comply with operating procedures to meet all cGMP and safety requirements. Responsible for all aspects of the laboratory operation, including calibration, qualification, and maintenance of laboratory equipment and supplies. Subject Matter Expert for regulatory audits related to QC Microbiology. Write Environmental Monitoring Trend Reports and prepare various presentations for Management staff. Oversee the implementation and validation of various Microbiology equipment for environmental monitoring, endotoxin testing and various lab equipment. Provide oversight of method validation projects for QC Microbiology for sterility, bioburden, LAL, All studies, etc. Show less Performing Sterility tests for Sterile products .- LAL test for both Sterile products & WFI water systems.- Insoluble Particulate matter test for sterile products.- Environmental monitoring of both Sterile & Non-sterile production areas & Microbiology Laboratory ( viable & non-viable tests) - WFI water systems analysis ( including Qualification period)- Microbial tests Validation & Qualifications.- Microbial Count for non-sterile products.- Media preparation & it's PH adjustment validation. - Microbiological assay for products & evaluation of disinfectants.- Growth Promotion Test.Microbial monitoring of pharmaceutical water using membrane filtration & pour plate techniques. •Microbial monitoring of air (active and passive), surfaces and personnel.•Microbiological control on sterile and non sterile pharmaceutical products.•Bacterial isolation, staining and identification through biochemical testing Show less

  • Microbiology Section Head

    Jan 2013 - May 2017

  • Microbiology Supervisor

    Jan 2009 - Dec 2012

  • Quality Control Microbiologist

    Jan 2007 - Dec 2008
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  ACDIMA

  Jun 2007 - Aug 2023

  Microbiology Section head

  Responsibilities:• Manage and oversee daily microbiology laboratory operations including supervision of Microbiologists and Technicians and ensure that all work carried out in compliance with the required regulatory standards, conforms to company policies and standard operating procedures (SOPs) • Provide, review and make recommendations for environmental trending and monitoring data for the production areas. Moreover, ensuring that robust contamination control strategies are developed and implemented.• Continuous evaluation and improvement of micro SOPs, test methods, work instruction, efficiency and cost and ensuring established safety and quality procedures are followed.• Support manufacturing personnel and other departments as required in the identification of microbiological root cause analysis and provide technical microbiological support and advice on QC related topics as needed.• Interpret test results and initiate additional testing as needed to confirm or isolate issues, using professional judgment and following established procedures. and Provide an assistance to troubleshoot and resolve product sterility issues.• Keep Quality management and plant management informed of micro issues that could impact production schedules, product release or GMP compliance.• Participate in external regulatory inspections, internal hygiene/QA audits and suppliers/ Co-Manufacturing Plant audits.• Management of Quality Control Microbiology training programs, develops training materials and continue to improve existing programs. Show less

• 

  Higher institute of applied health science

  Oct 2020 - now

  Lecturer of Medical and Pharmaceutical Microbiology

   Design and teaching of the following courses:• General Microbiology.• Bacteriology for medical laboratory technologist.• Mycology and virology for medical laboratory technologist.• Infection Control & Sterilization Techniques.• Practical Microbiology and basics of Molecular biology Teaching and learning support• Contribute to the planning, design and development of objectives and material including modules and programmers• Set, mark and assess work/examinations and provide feedback to students.• Communicate and disseminate complex and conceptual ideas in a variety of ways presentations, reports, learning materials, results of scholarly activity, feedback etc. Show less

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  UP PHARMA

  Jul 2023 - now

  Microbiology Manager

  1. Leadership and Team Management:• Lead, mentor, and manage a team of microbiologists, ensuring proper training, performance evaluations, and professional development.• Foster a collaborative and innovative work environment that encourages teamwork, communication, and knowledge sharing.2. Quality Control and Assurance:• Develop and implement microbiological testing protocols, procedures, and methodologies to ensure compliance with regulatory requirements and industry standards.• Oversee routine environmental monitoring, sterility testing, and microbial identification processes to ensure product safety and quality.• Review and approve analytical data, test results, and laboratory investigations to maintain accurate and reliable records.3. Regulatory Compliance:• Stay up-to-date with current industry regulations (such as cGMP, USP, and FDA guidelines) and ensure that laboratory practices and processes align with these standards.• Collaborate with regulatory affairs and quality assurance teams to address compliance issues and provide necessary documentation for audits and inspections4. Continuous Improvement:• Identify areas for process optimization, efficiency enhancement, and cost reduction within the microbiology laboratory.• Implement and oversee quality improvement initiatives to enhance overall laboratory performance and product quality.5. Budget Management:• Develop and manage the microbiology department's budget, ensuring effective allocation of resources for equipment, reagents, and personnel. Show less