Dynamic Industrial Pharmacist with over seven years of progressive experience in Quality Assurance within esteemed pharmaceutical organizations in Australia and Bangladesh. Expertise includes regulatory-compliant environments endorsed by TGA, U.S. FDA, MHRA, WHO, ISO, and other relevant authorities, ensuring adherence to stringent quality standards. Currently serving as a QA Associate (QMS) and Halal Supervisor at a leading pharmaceutical company in Australia, demonstrating a solid foundation in therapeutics, complementary medicines, veterinary products, and sterile manufacturing operations. Proficient in Good Manufacturing Practice (GMP) and adept at aligning with Good Laboratory Practice (GLP) requirements to foster robust quality systems and drive continuous process improvement.
Hi, I’m
Shahadat Hossin Sojib
Carlton,NSW
Summary
Overview
8
years of professional experience
Work History
Homart Pharmaceuticals Pty. Ltd.
Quality Assurance Associate
07.2024 - Current
Job overview
- External Audits Management: Handle audits from TGA, USFDA, ISO, HALAL, ACO, NSW Food Authority, DAFF, Customer Audit
- Quality Management: Perform Release For Supply, Manage Change Control, CAPA, and Deviation Management, Perform Quality Risk Assessment (FMEA Mode), Investigate OOS (Out of Specification) and OOT (Out of Trend) results, Investigate Customer Complaints with root cause analysis using Fish-Bone Diagram, Prepare and review SOP, Site Master File, Quality Manual & HACCP, Prepare Product Quality Review (PQR), Prepare training module and maintain training record.
- Internal Audits and Compliance: Perform Internal Audits and External Audit as per the yearly schedule, Monitor all QMS registers and logbooks related to equipment.
- Calibration and Equipment Management: Perform In-House Calibration (Weight Balance, Stability Chamber, Data Logger, pH Meter), Maintain and monitor external calibration, Review and approve Qualification (IQ/OQ/PQ) of equipment.
- Facility and Environmental Monitoring & Control: Perform Environmental Monitoring using Air Particle Counter, Maintain Pest Control Management.
- Halal Compliance: Act as Halal Supervisor, overseeing the implementation and enforcement of Halal compliance.
The ACME Laboratories Ltd.
Quality Assurance Executive
08.2019 - 02.2024
Job overview
- Quality Assurance activities were - Change Control Management, CAPA Management, Quality Risk Assessment, Deviation Management, Customer Complaint Handling with investigation, Annual Product Quality Review.
- Contented development of Quality documents conforming to cGMP regulations.
- Performed Internal Audit.
- Handled External Audit.
- Performed USFDA, MHRA, TGA, ISO and DGDA Audit.
- USFDA, TGA, MHRA, WHO, ISO 9001:2015 Certificate Handling
Euro Pharma Limited
Jr. Executive, Quality Assurance
04.2018 - 07.2019
Job overview
- Performed IPQA (In-Process Activities).
- Performed Batch Release and documentation.
- GAP analyzed the current GMP facility with respect to cGMP regulations.
- Performed Retention Sample Management.
Education
The University of Development Alternative (UODA)
Master of Pharmacy
University Overview
GPA: CGPA- 3.51 out of 4.00
State University of Bangladesh
Bachelor of Pharmacy
University Overview
GPA: CGPA- 3.80 out of 4.00
Skills
- Audit Management
- Release For Supply
- Change Control Management
- CAPA Management
- Customer Complaint Investigation
- Deviation Management
- In-House and External Calibration Management
- SOP Preparation and Implementation
Personal Information
Personal Information
Title: Industrial PharmacistLanguages
English
Full Professional
Timeline
Quality Assurance Associate
Homart Pharmaceuticals Pty. Ltd.
07.2024 - Current
Quality Assurance Executive
The ACME Laboratories Ltd.
08.2019 - 02.2024
Jr. Executive, Quality Assurance
Euro Pharma Limited
04.2018 - 07.2019
State University of Bangladesh
Bachelor of Pharmacy
The University of Development Alternative (UODA)
Master of Pharmacy