Akiful Haque
Senior Validation Engineer at Amphastar Pharmaceuticals, Inc.
- Role
- Senior Validation Engineer at Amphastar Pharmaceuticals, Inc
- Location
- Quincy, MA, US
- LinkedIn followers
- 500 followers
About Akiful Haque
Validation and quality professional with deep expertise in end-to-end qualification of…
Experience
Senior Validation Engineer
Amphastar Pharmaceuticals, Inc
May 2023 — Present · Canton, MA, US
Directed validation and qualification of pharmaceutical processes—micronization, compounding, filling, sterilization, packaging, and shipping—ensuring compliance with FDA, OSHA, and cGMP standards. Demonstrated expertise in process, equipment, facility management, cleaning validation, and commissioning of MDI commercial production lines in ISO Class 5, 7, and 8 environments. Developed and executed IOPQ protocols for automated systems, including I/O testing and HMI functionality assessments, ensuring 21 CFR Part 11 compliance and equipment integrity. Conducted environmental monitoring, such as temperature and humidity mapping with Kaye Validator, and performed Mean Kinetic Temperature (MKT) analysis. Led deviation management, resolved Non-Conformance Reports (NCRs), and managed Corrective and Preventive Actions (CAPA) and Change Control Requests (CCR) to maintain regulatory compliance. Directed large-scale MDI revalidation projects and administered a robust Process Cleaning revalidation program. Proficient in preparing and managing critical documentation, including Master Production Records (MPR), Standard Operating Procedures (SOPs), Master Validation Protocols (MVP), and comprehensive final report turnover packages.
Education
University of Massachusetts Lowell
Master of Science - MS
2019 — 2022
Islamic University of Technology
Bachelor of Science
2012 — 2016
University of Massachusetts Lowell
Doctor of Philosophy - PhD
2019 — 2023
Notre Dame College
HSC
2010 — 2012
Government Laboratory High School | Dhaka
SSC
2000 — 2010
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