Mainul Hoque

Senior pharmaceutical quality executive with 30+ years of progressive leadership experience in sterility assurance, aseptic processing, pharmaceutical microbiology, contamination control, validation lifecycle management, and global GMP compliance across sterile and non-sterile manufacturing environments. Proven track record of leading enterprise quality initiatives, inspection readiness programs, multi-site remediation projects, technology transfers, and facility start-up activities while maintaining uninterrupted product supply and regulatory compliance. Recognized for establishing robust contamination control strategies, microbiology laboratories, computerized quality systems, and validation frameworks supporting complex pharmaceutical operations.

Extensive expertise in aseptic processing, contamination investigations, environmental monitoring, media fill oversight, HVAC qualification, cleanroom compliance, process validation, cleaning validation, computerized systems validation, and quality risk management. Highly experienced in building and mentoring multidisciplinary teams, developing future leaders, and fostering a culture of quality excellence and continuous improvement. Collaborative leader with demonstrated success partnering with executive leadership, technical operations, engineering, manufacturing, regulatory affairs, and external stakeholders to deliver sustainable quality outcomes in highly regulated environments.

Manager, Validation - OPSONIN PHARMA LIMITED - Barishal, Bangladesh

(2022-04)

Lead enterprise validation and sterility assurance programs supporting sterile and non-sterile pharmaceutical manufacturing operations across multiple production facilities.

• Direct qualification and validation activities for HVAC systems, cleanrooms, water systems, utilities, manufacturing equipment, computerized systems, and aseptic processing operations.
• Provide strategic leadership for contamination control, aseptic process validation, environmental monitoring trending, and microbiological risk mitigation initiatives.
• Led qualification and validation activities for more than 100 critical manufacturing systems and equipment supporting GMP manufacturing operations.
• Executed over 600 process validation programs and cleaning validation activities across 48 manufacturing lines, strengthening process reliability and regulatory compliance.
• Led 15+ HVAC qualification and cleanroom validation projects supporting sterile manufacturing and controlled environments.
• Directed media fill and aseptic process simulation programs to ensure sterility assurance and contamination control effectiveness.
• Collaborate with Quality, Engineering, Manufacturing, and Technical Services teams to ensure FDA-aligned compliance and inspection readiness.
• Support implementation and governance of eQMS, eBR, and LIMS systems for microbiological data trending and compliance monitoring.
• Drive deviation investigations, CAPA effectiveness reviews, risk assessments, and remediation activities for critical quality events.
• Serve as senior SME for microbiology, sterility assurance, contamination investigations, and validation lifecycle management.

Manager, Quality Assurance - OPSONIN PHARMA LIMITED - Barishal, Bangladesh

(2017-01 - 2022-04)

Led QA operations across manufacturing and support functions, ensuring adherence to cGMP, GDP, data integrity expectations, and internal quality systems.

• Led site-wide Quality Assurance operations for multi-site pharmaceutical manufacturing and technology transfer projects.
• Directed GMP compliance, inspection readiness, deviation management, change control, risk management, and quality systems governance.
• Successfully led multi-site transfer activities from old manufacturing facilities to new production sites while maintaining uninterrupted GMP compliance.
• Managed large cross-functional QA teams supporting sterile and non-sterile pharmaceutical operations.
• Authored and approved more than 1000 SOPs, quality procedures, validation protocols, and compliance documentation.
• Developed and implemented Validation Master Plans (VMP), Site Master Files (SMF), and enterprise quality systems aligned with international GMP expectations.
• Led regulatory preparation and compliance activities supporting licensing inspections and GMP certifications.
• Partnered with executive leadership to strengthen quality culture, compliance performance, and operational excellence initiatives.
• Conducted vendor qualification and GMP audits of API, excipient, packaging material, and service providers across Bangladesh, India, and China.
• Directed quality risk management initiatives and remediation programs to improve compliance effectiveness and reduce repeat deviations.

Manager, Microbiology & Validation - JAYSON PHARMACEUTICALS LIMITED - Dhaka, Bangladesh

(2013-05 - 2016-12)

Directed microbiology and validation functions for sterile and non-sterile manufacturing support, including environmental monitoring, water systems, gas testing, and validation lifecycle activities.

• Established and improved contamination control, cleaning validation, process validation, and equipment qualification practices in line with GMP requirements.
• Supported technology transfer and site quality systems during facility expansion and operational scale-up.

Assistant Manager, Microbiology & Validation - LABAID PHARMACEUTICALS LIMITED - Dhaka, Bangladesh

(2010-05 - 2013-04)

Managed microbiological control programs, qualification support, and validation documentation for regulated pharmaceutical operations.

• Contributed to aseptic assurance, utility monitoring, investigation support, and cross-functional GMP compliance activities.

Master of Science in Microbiology

Victoria University, USA

Bachelor of Science in Biological Science

Certification on Six Sigma Black Belt

Project Management Institute, USA

Audit Readiness and Managing the inspection

Computer System Validation

Quality Risk Management