- Lead and oversee the QC Methodology Section, ensuring all laboratory activities comply with regulatory and company standards.
- Develop, validate, and implement analytical methods for pharmaceutical product testing.
- Supervise and mentor a team of quality control analysts and specialists, fostering a culture of continuous improvement.
- Review and approve technical documents, including method validation protocols, SOPs, and analytical reports.
- Ensure timely and accurate completion of all quality control testing and documentation.
- Investigate and resolve non-conformities, deviations, and out-of-specification results in accordance with GMP guidelines.
- Maintain up-to-date knowledge of industry trends, regulatory requirements, and technological advancements in QC methodologies.
- Manage laboratory resources, including equipment calibration, maintenance, and inventory control.
- Development of analytical procedures for drug products under development.
- Validation of the developed analytical procedures according to ICH guidelines.
- Handling troubleshoots during product development.
- Periodical review of developed analytical methods.
- Respond to relevant requirements of the registration & export departments.
- Capable in managing, training, and coaching staff to achieve the lab KPIs.
Ensures that all activities in his unit or section are done according the relevant cGMP and ISO standards