QC Methodology Section Head

Rameda

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