Biomedical Sciences graduate with a focus on Drug Design and Discovery/Molecular Biology and hands-on experience in R&D, aiming for a role in Quality Assurance. Possesses a strong background in laboratory practices, quality control, and compliance with research standards, alongside experience in documenting API specifications. Skills will be applied to ensure product quality in pharmaceutical or healthcare settings. Passionate about maintaining high-quality standards through detailed inspection, validation, and collaboration with production teams.
Implemented over 100 raw material specifications for APIs, excipients, and packaging materials to ensure use of high-quality materials and prevent unwanted substances in drug products.
Developed and implemented over 50 packaging material specifications to enhance stability of drug products and provide optimal protection against environmental factors.
Established over 30 Standard Operating Procedures (SOPs) for raw material specifications and methodologies for Differential Thermal Scanning and Malvern Master Sizer 300, ensuring consistency and reliability in testing.
Maintained calibration for both Differential Thermal Scanning and Malvern Master Sizer 300 instruments, achieving over 95% compliance with calibration standards.
Submitted more than 100 specifications tailored for export authorities, including preparing cover letters that justify specifications and ensure regulatory compliance.
Implemented Good Manufacturing Practices (GMP) and Good Laboratory Practices (GLP) across all processes, resulting in 20% reduction in deviations and ensuring adherence to industry standards.
Organizational and planning skills
Decision-making
Good listener and communicator
Data Integrity
Motivated
Analytical skills
Team-work oriented
Microsoft Office
Microsoft Powerpoint
SAP
Microsoft Excel
lims
Microsoft Word
Advanced knowledge in webinar tools (eg, Zoom) and learning management systems (eg, Moodle)
Data Collection
Monitoring and Evaluation
Adaptive Learning
SAP user
Microsoft Office
Lims
Quality Assurance
Regulatory Affairs
Clinical research