Highlights:30+ Years of Experience: Extensive background in pharmaceutical validation, quality systems, and microbiology, ensuring compliance with FDA, EU, and international regulatory requirements. Leadership in Validation and Quality Assurance: Led large-scale validation projects across multi-site operations, overseeing process, cleaning, computer system validation, and equipment qualification. Directed the implementation of validation master plans, delivering project milestones on time and within regulatory standards. Expert in Regulatory Compliance: Successfully managed regulatory audits (FDA, EMA) and achieved certification in alignment with global standards (PIC/S, GMP). Expert in designing and executing validation protocols, cleanroom qualification, and aseptic processing, ensuring sterility assurance. Risk Management & Process Optimization: Proven track record in applying risk-based approaches (FMEA, HACCP, HAZOP) for validation and qualification processes. Reduced microbial contamination by 18% and improved lab productivity by 25% through process optimization and strategic leadership. Global Certifications & Technical Expertise: Certified in Six Sigma, GAMP5, Data Integrity, 21 CFR Part 11, and Computer System Validation. Practical experience with eQMS, eBR, LIMS, and ERP systems for quality control and microbiology data trending. Open to Relocation and Visa Sponsorship: Actively seeking a leadership role in validation management, bringing advanced expertise in sterile pharmaceutical processes and strong leadership skills, ready to relocate to the USA under a visa sponsorship program.

Skills:Pharmaceutical Quality System, Validation, Vendor Qualification, Cleanroom Qualification, IQ/OQ/PQ of Equipment, HVAC, Water system, Training and Mentoring, Technology Transfer, QA project Management, Technical Writing, Power point Presentation, Leadership, Conflict Management, Cleaning Validaion, Risk-Based Validation, Aseptic Processing, Sterility Assurance, Contamination Control Strategy (CCS), DA, EU, and GMP Compliance, GAMP5, 21 CFR Part 11 Compliance, Quality Risk Management (QRM), Quality Systems Audits, Change Control Management, Root Cause Analysis (RCA), Data Integrity Compliance, Six Sigma Certification, Hazard Analysis and Critical Control Points (HACCP, Failure Mode and Effects Analysis (FMEA), Fault Tree Analysis (FTA), Sterilizer Validation, emperature Mapping, Project Planning and Execution, Regulatory Inspections & Audits, Team Leadership & Training, Continuous Improvement, People Development and Mentoring, Expert Validation Manager, Compliance (GMP, FDA, EU regulations), Microbiology Lab Management, eQMS, LIMS, ERP, Data Integrity, GAMP5, 21 CFR Part 11, Led validation projects for sterile manufacturing, Developed and implemented contamination control st, Managed vendor qualification and quality risk mana, Cleaning Validation, Expert Trainer on Validation, Quality Assurance, Calibration Management of Pharmaceuticals, Expert on New QA Department set up, Expert on Validation Project set up

Goal:To ensure the desired quality for the patient safety and achieve the customer satisfaction applying updated regulatory guidelines. To leverage over 30 years of expertise in pharmaceutical validation, sterile processing, and quality systems to drive compliance, innovation, and operational excellence. My goal is to lead global pharmaceutical operations, ensuring high standards of safety, regulatory compliance, and efficiency. I aim to contribute to the continuous improvement of validation processes and quality assurance systems, while fostering a culture of excellence and teamwork in multinational settings.

Membership:Life Member, Membership No. LM-044 Bangladesh Society for Pharmaceuticals Professional Member of LinkedIn Discussion Group of Pharmaceuticals Validation Admin of LinkedIn Discussion Group of Bangladesh Pharmaceuticals Microbiology Forum (BPMF)

Certification:Six Sigma Green Belt Diploma in Human Resources Computer System Validation (CSV) Validation Master Plan (VMP) Data Integrity 21 CFR Part 11 Compliance Process Validation Strategic Management and Leadership Diploma in Human Resources Drugs and the Brain Quality Risk Management Vendor Management SOP, Protocol and Site Master File Digital Product Quality Review Robust Data integrity and Quality Consideration

Honor:op Quality Management Voice (LinkedIn Recognition) Recognized for expertise and thought leadership in pharmaceutical quality management, validation, and compliance. Top Teamwork Voice (LinkedIn Recognition) Awarded for exceptional leadership and collaborative efforts in fostering teamwork and driving cross-functional success within pharmaceutical operations. Achieved PIC/S Certification Successfully coordinated Aseptic Process Simulation and cleanroom qualification programs, leading to PIC/S certification for a sterile manufacturing facility. Leadership in Multi-Site GMP Certification Led the quality assurance team to secure GMP certification and regulatory licenses from local FDA for a new multi-site facility, achieving high compliance standards. Process Optimization Excellence Reduced microbial contamination by 18% and improved lab productivity by 25% through environmental monitoring and process optimization in sterile manufacturing. Technology Transfer of Multiples QA and Validation Project : Directed and organized technology transfer system from old manufacturing plant to new six manufacturing plant with more 1000 products

Manager, Validation 03/2022 - current
Opsonin Pharma Limited, Barishal, Bangladesh
Industry: Pharmaceuticals
Accomplished Validation Manager with long experience in pharmaceutical quality systems and validation across multi-site operations. Proven expertise in developing and implementing comprehensive validation strategies for sterile processing, cleanroom qualification, process validation, and computer system validation (CSV), ensuring compliance with FDA, EU GMP, and international regulatory standards. Skilled in risk-based approaches (FMEA, HACCP, HAZOP) and achieving operational excellence through process optimization. .
• Led the development and execution of risk-based Validation Master Plans, driving compliance with FDA, EU, and international standards across multi-site operations. • Managed process validation for parenteral manufacturing, including sterile products like SVP, LVP, lyophilized products, pre-filled syringes, biosimilars, and insulin, ensuring consistent high-quality outcomes. • Spearheaded Computer System Validation (CSV), optimizing data integrity in alignment with GAMP5, WHO, and MHRA guidelines, reducing compliance gaps by 15%. • Enhanced cleanroom validation processes, ensuring environmental control and aseptic conditions, contributing to a 20% improvement in contamination control. • Successfully led internal audits and regulatory inspections, minimizing non-compliance issues, including effective resolution of OOS (Out-of-Specification) and OOT (Out-of-Trend) findings. • Trained and developed a cross-functional team of 25+ QA professionals, increasing team efficiency by 25% through enhanced compliance training programs.--
Manager, Quality Assurance 01/2017 - 03/2022
Opsonin Pharma Limited, Barishal, Bangladesh
Industry: Pharmaceuticals
Experienced Quality Assurance Manager with over 5 years of expertise in managing and implementing robust quality management systems within pharmaceutical manufacturing environments. Skilled in ensuring compliance with global regulatory standards, including FDA, EU GMP, and ICH guidelines, through the development and enforcement of SOPs, validation protocols, and quality policies. Led multi-site QA teams in conducting vendor audits, risk assessments, deviation management, and change control
Led comprehensive quality oversight of the multi-site transfer of manufacturing operations and Laboratory management achieving GMP certification and regulatory approval for sterile dosage forms such as lyophilized, ophthalmic, ampoule, micro dose and pre-filled syringes. Established three critical departments—Quality Assurance, Microbiology, and Validation Laboratories—ensuring alignment with WHO and ISPE guidelines for sterile manufacturing Managed cross-functional teams in complaint investigation management, significant deviation management, and GMP archive oversight, driving process improvements and minimizing compliance gaps across multi-site operations. Developed and mentored a diverse team of quality personnel, fostering a culture of safety, compliance, and continuous professional growth, while enhancing team capabilities in inspection readiness and regulatory interactions. Spearheaded critical compliance initiatives, led cross-site benchmarking and networking for best practice implementation, and ensured effective quality decision-making in high-impact situations requiring senior-level approvals.--
Manager, Microbiology & In-Charge, Validation 05/2013 - 12/2016
Jayson Pharmaceuticals Limited, Barishal, Bangladesh
Industry: Pharmaceuticals
To ensure Microbiological analysis, environmental monitoring, cleaning validation, Analytical Method Validation, Microbiology Lab. Management, Hiring and train up the personnel on updated regulatory guideline, follow best Microbiology Laboratory Practice for patient safety
• Ensured microbiological quality control for raw materials, in-process, and finished products, reducing microbial contamination by 18% through optimized environmental monitoring. • Developed and executed comprehensive cleanroom qualification programs, enhancing the sterility assurance in the production of sterile pharmaceutical products. • Successfully coordinated Aseptic Process Simulation (media fill) for sterile products, ensuring compliance with international regulatory standards and achieving PIC/S certification. • Led the design and establishment of a high-performance microbiology laboratory, improving productivity by 25% through process optimization.--
Asst. Manager, Microbiology and Validation 05/2010 - 05/2016
Labaid Pharmaceuticals Limited, Dhaka, Bangladesh
Industry: Pharmaceuticals
To ensure the project progress of Microbiology, QA, PD as per project planning, Improvement, follow up the microbiological analysis, Method Validation, Quality Risk Management, Third parties working activities checking, trend analysis, mitigation plan, people development through training
• Established and structured the Microbiology and Quality Control laboratories, ensuring adherence to international standards and increasing efficiency in testing and reporting by 20%. • Improved quality risk management processes using tools such as FMEA and HACCP, leading to a 15% reduction in quality incidents. • Played a critical role in implementing Validation Master Plans, ensuring robust qualification protocols for all major production equipment and cleanroom environments.--
Sr. Microbiologist 01/2001 - 04/2010
Opsonin Pharma Limited, Barishal, Bangladesh
Industry: Pharmaceuticals
To organize and provide consultancy for implement microbiological analysis, Lab. Management to ensure data integrity, Biological analysis by software basis, ensure aseptic process simulation
Directed microbiological lab operations, overseeing cleanroom validation, sterility testing, and environmental control in sterile manufacturing, improving product sterility assurance. Led routine GMP internal audits, ensuring compliance across all departments and identifying areas for continuous improvement. Conducted comprehensive aseptic process simulations, ensuring manufacturing processes adhered to the highest sterility standards.--
Microbiologist 04/1999 - 12/2000
Kumudini Pharma Limited, Narayangonj, Bangladesh
Industry: Pharmaceuticals
Highly experienced Microbiologist specializing in pharmaceutical quality systems, laboratory setup, and microbiological testing of raw materials, in-process samples, and finished products. Skilled in managing lab equipment calibration, including autoclaves, sterilizers, and incubators. Proficient in preparing microbiology reports, environmental monitoring, personnel hygiene checks, and maintaining standard microorganisms. Ensures compliance with pharmacopeia and in-house specifications for sterile processes and culture media QC.
Microbiological Analysis: Perform comprehensive microbiological testing on raw materials, in-process samples, and finished products to ensure safety and compliance with regulatory standards. Laboratory Setup & Equipment Management: Set up and maintain microbiology laboratories, ensuring compliance with GMP and regulatory standards. Calibrate and perform routine performance checks of critical equipment, including autoclaves, dry heat sterilizers, and incubators. Documentation & Reporting: Prepare and maintain detailed microbiology analysis reports, environmental monitoring reports, and personnel hygiene check records. Establish specifications as per pharmacopeia and in-house standards for testing procedures. Environmental Monitoring & Personnel Hygiene: Conduct environmental monitoring and personnel hygiene checks to ensure contamination control in sterile areas. Culture Media & Microorganism Management: Ensure the quality control of culture media, including periodic maintenance and re-standardization of standard microorganisms. Maintain periodic culture revalidation and oversee media QC checking processes to ensure accurate and reliable results. Quality Assurance: Implement and maintain SOPs, test procedures, and all required documentation related to microbiological testing and laboratory management.--
Junior Officer, Microbiology 09/1994 - 04/1999
ACI Pharmaceuticals Limited, Narayangonj, Bangladesh
Industry: Pharmaceuticals
Results-driven Microbiologist with extensive experience in pharmaceutical microbiology, specializing in microbiological analysis of starting materials and finished products, autoclaving, and conducting sterility testing and media fill validation for sterile ampoule manufacturing lines. Skilled in environmental monitoring through RCS air sampling, water analysis, and pyrogen testing of injections. sample collection, and maintaining compliance with pharmacopeial standards and GMP regulations. Committed to ensuring product quality and safety in sterile environments.
Microbiological Testing: Perform microbiological analysis of starting materials and finished products to ensure compliance with pharmacopeial and GMP standards. Media Preparation & Autoclaving: Prepare microbiological media and conduct autoclaving of media and materials. Perform autoclave validation to ensure proper sterilization and compliance with validation protocols. Sterility Testing & Media Fill Validation: Conduct sterility testing for finished products and perform media fill validation for sterile ampoule manufacturing lines, ensuring aseptic integrity. Environmental Monitoring: Perform environmental monitoring using RCS air sampling for sterile vial, ampoule, and antacid manufacturing areas to assess contamination levels in cleanroom environments. Water & Pyrogen Testing: Perform water analysis and pyrogen testing for injectable products, ensuring compliance with pharmacopeial standards. SOP Preparation & Sample Collection: Prepare and update Standard Operating Procedures (SOPs) for microbiological testing, sampling, and sterilization processes. Collect and handle samples according to SOPs to ensure traceability and proper documentation. Regulatory Compliance: Ensure all microbiological testing and sterilization processes comply with regulatory guidelines, GMP standards, and pharmacopeial specifications.--

University of Dhka, Bangladesh 01/1989 - 12/1993
Dhaka, , Bangladesh
Degree: Bachelor's Degree
Major:Biology
Minor:Botany, Zoology and Chemistry
Medical Microbiology Plant Pathology Zoology Organic and inorganic chemistry Physical Chemistry

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