Tareek Aadnan

Quality Assurance professional with 10+ years of experience in US FDA-approved pharmaceutical manufacturing environment (Beximco Pharmaceuticals PLC). Proven expertise in GMP compliance, deviation/CAPA systems, batch record review, and regulatory inspection readiness across US FDA, EU GMP, WHO, and TGA frameworks. Strong practical knowledge of quality systems aligned with ICH Q7, Q9, Q10 and EU GMP Annex 1 and Annex 15 requirements.

Experienced in supporting validation lifecycle activities, quality risk management, and maintaining inspection-ready quality systems in regulated manufacturing environment. Demonstrated capability in cross-functional GMP compliance support and continuous quality improvement initiatives.

Assistant Manager – Quality Assurance - Beximco Pharmaceuticals PLC - Gazipur, Bangladesh

(2024-01)

Main activities and responsibilities

• Manage deviation investigations (approx. 40–50 annually), including root cause analysis and CAPA implementation
• Perform batch record (BMR) and analytical data review to support batch release decisions
• Review market complaint investigations and ensure appropriate corrective actions
• Participate in Annual Product Quality Review (APQR) activities
• Conduct risk assessments in line with ICH Q9 for change control and quality events
• Ensure compliance with data integrity principles (ALCOA+)
• Ensured timely deviation closure and CAPA implementation within defined quality timelines
• Maintained inspection-ready state with successful outcomes during regulatory audits
• Supported regulatory inspection readiness, audit response coordination, and CAPA implementation in line with global GMP expectations
• Ensure compliance with EU GMP requirements, including familiarity with Annex 1 and Annex 15 principles for qualification and validation
• Support validation lifecycle activities including process validation, cleaning validation, and continued process verification in line with GMP requirements
• Ensured batch documentation completeness and GMP compliance to support Qualified Person (QP) review and batch certification in regulated markets

Senior Officer – Quality Assurance - Beximco Pharmaceuticals PLC - Gazipur, Bangladesh

(2019-01 - 2024-01)

• Supported deviation, OOS, and CAPA management activities
• Performed batch record and analytical data review for batch release
• Participated in APQR and quality system activities
• Supported validation lifecycle activities including process validation (Stage 1–3), cleaning validation (MACO-based assessment), and equipment qualification (IQ/OQ/PQ) in compliance with EU GMP Annex 15
• Contributed to audit preparation and documentation compliance

Officer – Quality Assurance - Beximco Pharmaceuticals PLC - Gazipur, Bangladesh

(2016-01 - 2019-01)

• Conducted in-process QA monitoring and line clearance
• Supported validation and qualification activities
• Assisted in deviation and CAPA documentation
• Performed documentation review for batch release

Officer – Quality Assurance - General Pharmaceuticals Limited - Gazipur, Bangladesh

(2015-01 - 2016-01)

• Performed in-process QA activities and line clearance
• Supported process and cleaning validation
• Assisted in deviation, OOS, and CAPA documentation
• Ensured GMP documentation compliance

Master of Pharmacy - Clinical Pharmacy & Pharmacology - Noakhali Science and Technology University

Bachelor of Pharmacy - Noakhali Science and Technology University