Md Mainul Hoque Email and Phone Number
With over thirty years of experience as a Manager, Quality Assurance, Validation & Microbiology at Opsonin Pharma Ltd, Prior to joining I worked in different leading Pharmaceuticals company in Bangladesh in Quality Assurance Department. The certification in Drugs and the Brain from Caltech, Six sigma Green Belt, Data integrity & Computer system Validation/Assurance, Qualification, Deviation/Change Control Management, Root Cause Analysis, Complaint, recall from USP education. Based on my extensive experience in the pharmaceutical industry, here are some key achievements that highlight my expertise:Comprehensive Validation Management: Successfully managed the qualification and validation activities across six pharmaceutical manufacturing plants, ensuring compliance with regulatory standards and supporting multiple GMP inspections.Protocol Development: Authored over 600 validation protocols for critical processes and cleaning, demonstrating a strong commitment to maintaining high quality standards and regulatory compliance.Vendor Qualification: Completed more than 3,000 vendor qualifications, ensuring that all suppliers met stringent quality criteria and aligning with US FDA 21 CFR, ICH, EMA, ISO, PIC/S, and WHO guidelines.Risk Management Expertise: Developed over 200 Quality Risk Management documents, enhancing the organization’s ability to identify and mitigate potential quality risks effectively.Training and Development: Conducted numerous training sessions, empowering employees with knowledge in Pharmaceutical Quality, QA Validation, and compliance, thus fostering a culture of continuous improvement.Process Validation Leadership: Led successful process validation initiatives, ensuring the consistent quality of products in Beta lactam, steroid, hormone, and oncology manufacturing.Technology Transfer: Managed the technology transfer of 900 products to a new pharmaceutical manufacturing plant, ensuring seamless transitions and minimal disruptions.Quality System Establishment: Played a pivotal role in establishing quality systems for two major projects, aligning processes with industry best practices and regulatory requirements.Sterility Assurance: Developed expertise in sterilization processes and aseptic simulations, contributing to enhanced sterility assurance and cleanroom qualification.Continuous Improvement Initiatives: Evaluated and investigated quality defects, leading to process improvements and reduced error rates, thereby enhancing overall product quality.
Opsonin Pharma Ltd
View- Website:
- opsonin-pharma.com
- Employees:
- 1200
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Manager Validation ( Head Of Validation Department)Opsonin Pharma LtdBarisal Division, Bangladesh
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Manager ValidationOpsonin Pharma Ltd Apr 2022 - PresentRupatali BarishalLead the development and implantation of scientifically strong validation standard ensuring comprehensive planning, execution, and documentation of quality assurance and validation activities for pharmaceutical manufacturing processes, equipment, and systems.Develop and maintained robust validation master plans, protocols, cleanroom validation, and environmental control reports, ensuring compliance with FDA, EU, and international regulatory requirements.Direct and manage high-level GMP validation projects from concept through process validation, adhering to approved Validation Master Plan (VMP) and Corporate Policies and Procedures.Author and lead validation efforts for vendors, cleaning, quality assurance systems, sterile manufacturing, sterility assurance, aseptic process simulation, sterilizer validation, and environmental qualification.Maintain multi-site validation databases and documentation systems, supporting feasibility studies, equipment review, selection, acquisition, and upgrades.Establish a strong aseptic culture for operational management, sterility assurance, CCS, and environmental control in sterile processing areas.Lead, Direct and organize the Vendor Audit, Risk management of Raw Materials manufacturer, Periodic evaluation, approve or reject the vendor, control the vendor.Organize and directed comprehensive vendor audit schedules, risk management, and re-audits, aligning with APIC, ICH, and EUGMP guidelines.Provide strategic direction for validation philosophies, enhancing overall validation systems and processes incorporated into the VMP.Implement and periodically reviewed vendor/process-based risk management, applying risk-based approaches to all qualification types, eg. process validation (PV), cleaning validation (CV), vendor qualification, and computer system validation/computer software assuranceFoster the development of team members through regular training sessions, ensuring the implementation and updating of quality systems.
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Manager, Quality AssuranceOpsonin Pharma Ltd Jan 2017 - Apr 2022Barisal District, Barisāl, BangladeshOversaw the release or rejection of finished products by scrutinizing batch history to ensure compliance with approved product specifications.Monitored and communicated with QA personnel of Penicillin Production Building and Cephalosporin Production to ensure quality standards as per procedure.Inspected different production area in order to monitor day to day activities.Retained batch history as per guidelines for possible future use in data analysis.Monitored deviations, CAPAs, QIRs, OOS, change control, and quality risk management activities in the QA Department by comparing guidelines of cGMP, ICH, and PIC/S.Approved certificates of analysis by scrutinizing in line with specifications to meet customer demand.Executed and implemented any changes by coordinating with different departments/sections for improvement.Arranged to monitor real-time stability study of regulated products as per stability study protocol to assess, predict and confirm product shelf life under the climatic conditions expected during trade storage, shipping, house storage, and use.Monitored validation activities such as Process Validation, Cleaning Validation, Analytical Method Validation as per approved validation protocol to achieve WHO-cGMP standard of products.Approved and monitored Qualification of Equipment, utilities as per approved Qualification ProtocolPrepared and sent QA activity reports, non-conformity reports, storage condition assessment reports, and corrective action meeting minutes as per official procedures to the top management for information and necessary adviceEnsured proper recall system as per SOP where required when a serious product complaint is raised from the customer.Conducted meetings/training/workshops within the organization for different issues.Monitored and approved Annual Quality Review of products.Prepared departmental budget by analyzing previous data for the smooth running of the department.Prepared annual performance appraisal reports
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Manager, Microbiology & In-Charge, ValidationJayson Group Of Companies May 2013 - Dec 2016231, Tejgaon Industrial Area, DhakaEnsured that Sterile manufacturing area is controlled according to ISO 14644-1.Approve all microbiological test reports of raw materials, in-process and finished products.Conduct and plan the training program for microbiology personnel as per training schedule or as required.Conducted temperature mapping in raw materials store, packing materials store, and transportation according to cGMP requirements.Verified that the clean room for aseptic production area is maintained with required air classification.Simulated the aseptic process and ensure that all sterile products are free from the risk of the customer.Monitored the water system such as generation, preservation, and distribution and provide quality water for manufacturing.Ensured calibration and validation of all microbiology instruments.Organized Media Fill Validation, Sterilizer Validation, LAF, and other microbiology validation.Ensured environmental monitoring of sterile and non-sterile processing areas.These responsibilities are critical to ensuring the safety and efficacy of the products being manufactured. It is a high level of attention to detail, technical knowledge, and regulatory compliance. As such, it was utmost importance and carried out with diligence.Achievement: Led the microbiology and validation departments and ensured compliance with regulatory requirements. Conducted environmental monitoring and analysis of raw materials, finished products, and utilities. Developed and implemented validation plans, protocols, and reports for various types of equipment and processes. Collaborated with cross-functional teams to support new product launches and process improvements -
Assistant Manager, Microbiology & ValidationLabaid Pharmaceuticals Limited May 2010 - Apr 2013Genda, Savar, DhakaSuccessfully selected and procured appropriate equipment and supplies for the QC and Microbiology labs, ensuring that they met the requirements of the department and were obtained at a reasonable cost.Improved the efficiency and effectiveness of the QA department by updating and initiating changes to microbiology laboratory processes and environmental monitoring schedules.Successfully led the validation of HVAC and water systems, ensuring that they met regulatory guidelines.Worked as a team leader to provide support on all types of microbiological activities, resulting in an improved work output from the QA team.Successfully set up the Quality Assurance Department, including the design of lab furniture and positioning of equipment, which enabled the team to work more efficiently.Achievement of project work :Smooth support and coordination: My ability to communicate effectively with different departments and third parties helped to ensure that all QC, PD, and microbiology activities were supported and coordinated efficiently, leading to successful project work progress.Regulatory compliance: I was able to successfully implement all QA activities with standard regulatory guidelines and ensured that all documents were prepared to face GMP inspection of Bangladesh Drug Administration, which helped maintain regulatory compliance and avoid any issues during inspections.Leadership and motivation: I was able to motivate the QA personnel and lead the team, even in the absence of the QA Manager. This demonstrated your leadership skills and ability to manage and supervise the QA project work effectively.Laboratory set up and validation: I was responsible for the set-up and positioning of laboratory furniture, installation of all QC and microbiology equipment, and HVAC and water system validation. Successful completion of these tasks helped to ensure the smooth functioning of the laboratory and maintain the quality of products. -
Sr. MicrobiologistOpsonin Pharma Ltd Jan 2001 - May 2010Bogura Road, BarisalEnsure all microbiology test as per specification. Monitor Bacterial Endotoxin Test Quanititatively using by Endoscan-V Kinetic LAL Analyzer and validate new products as per standard method Ensure Sterility test, sterility test method validation of new product, Antimicrobial Preservative Efficacy Test of oral liquid, parentental preparation. Organize all validation and calibration such as Sterilizer, Media fill & all kinds of equipments of microbiology lab. Identify the source of contamination and identify the bacteria Train up all Microbiology personnel Distribute and Planning of all work among the test personnel Prepare and update Standard Operating Procedure, Test Method and others microbiology procedure Ensure compliance of all microbiological activities as per cGMP.Ensure Effluent Test such as Biological Oxygen Demand (BOD) and Chemical Oxygen Demand as per standard method. Prepare monthly microbiological activities. Develop method and update specification. Prepare yearly working schedule of Validation of Media Fill, Sterilizer, all types of water Raise the requisition of Microbiological Instruments and all media and reagents.Preserve all microbiology documents such as quality records, quality manuals.
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MicrobiologistKumudini Pharma Limited Jun 1999 - Dec 2000Narayanganj, Dhaka, BangladeshConducted all microbiological tests, including raw materials (RM), in-process control (IPC), and finished product (FP) testing, ensuring accuracy and compliance with established protocols.Performed personal hygiene checks and environmental monitoring in production areas to ensure a sterile and compliant manufacturing environment.Supervision:Supervise all microbiological activities within the department, ensuring adherence to quality standards and regulatory requirements.Documentation:Prepare and maintain SOPs, test methods, and all relevant test reports as per regulatory requirements.Quality Records Management:Maintain accurate documentation, quality records, environmental monitoring data, and water test reports to support quality assurance processes.Reporting:Prepare and present monthly reports on microbiology activities to departmental management, highlighting key findings and trends.Quality Control Procedures:Develop and implement quality control procedures to ensure the accuracy and reliability of microbiological test results.Cross-Department Collaboration:Collaborate with other departments to identify and resolve quality issues, facilitating a cohesive approach to quality management.Investigations and Root Cause Analysis:Conduct investigations and root cause analyses of quality deviations, implementing corrective actions to prevent recurrence.Audit Participation:Participate in internal and external audits to ensure compliance with regulatory requirements and company policies.Training and Development:Provide training to staff on microbiological testing procedures and best practices, fostering a culture of quality and continuous improvement.Data Analysis statistical analysis software to evaluate microbiological data and generate insights to enhance testing accuracy.Method Development:Contribute to the development of new microbiological testing methods or techniques to improve laboratory efficiency and effectiveness. -
Junior Officer, Microbiology Lab.Aci Pharmaceutical Limited Sep 1994 - Jun 1999Water Works Road, Godnyle, NaryangonjConducted microbial count of raw materials and finished products.Conducted pyrogen tests as per standard microbiological methods.Conducted bioassays for raw materials and finished products.Performed antimicrobial preservative tests for oral liquid.Performed sterility tests of sterile raw materials and finished products.Conducted environmental monitoring by RCS air sampler in non-sterile and sterile areas.Conducted broth filling and sterilizer validation as per standard microbiological methods.Collected samples such as all types of water, raw materials (for antacid preparation and others), and finished products for microbiology testing.Supervised animal house for smooth support of pyrogen tests and toxicity tests.To enhance your job responsibilities, I also want to consider adding some of the following responsibilities:Developed and implemented quality control procedures to ensure accuracy and reliability of test results.Collaborated with other departments to identify and resolve quality issues.Conducted investigations and root cause analyses of quality deviations.Participated in internal and external audits to ensure compliance with regulatory requirements.Provided training to staff on microbiological testing procedures and best practices.Utilized statistical analysis software to evaluate microbiological data.Contributed to the development of new microbiological testing methods or techniques.Prepared reports on microbiological testing results and presented them to management or regulatory bodies.Achievement: Conducted microbiological testing on pharmaceutical products, raw materials, and water samplesPrepared and reviewed SOPs and protocols for microbiology laboratory testingAssisted in the development of a Quality Assurance System for the organization.
Md Mainul Hoque Education Details
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Victoria University, UsaMaster Of Science - Ms -
Bachelor'S Degree -
Govt. City College, ChittagongHigher Secondary Certificate
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Municipal Preparatory Secondary School, JashoreSecondary School Certificate
Frequently Asked Questions about Md Mainul Hoque
What company does Md Mainul Hoque work for?
Md Mainul Hoque works for Opsonin Pharma Ltd
What is Md Mainul Hoque's role at the current company?
Md Mainul Hoque's current role is Manager Validation ( Head of Validation Department).
What schools did Md Mainul Hoque attend?
Md Mainul Hoque attended Victoria University, Usa, University Of Dhaka, Govt. City College, Chittagong, Municipal Preparatory Secondary School, Jashore.
Who are Md Mainul Hoque's colleagues?
Md Mainul Hoque's colleagues are Depok Roy, Shariful Islam, Mahamud Shoaib, Asaduzzaman Asad, Partho Mahato, Md.ashik Mostafa, Ahmed Mamun.
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Md Mainul Hoque
Software Engineer || Software Development || Fintech || Python | DjangoChattogram, Bangladesh -
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