Ensure that all processes in the lab in accordance with cGMP amp GLP requirements Ensure that all equipment in the department are calibrated and validated according to a planned maintenance schedule Ensuring that all staff under my command are properly trained to perform their tasks and undertake their responsibilities Setting up and revision of Standard Operating Procedures to ensure that the current practices are in accordance with the written procedures which should reflect the current good laboratory practice Ensure that the implementation of Health amp Safety and other legal requirements Take part in staff recruitment and oversee the career development of his staff Ensure that the appropriate comparative dissolution files are well done for submission to MOH Ensure that the appropriate documents which required for registration process in EGYPT eCTD are well done and submitted at appropriate time Prepare method transfer protocol and follow up analysis results in apex QC LAB and receiving unit until issuing method transfer report for registration purpose in To ensure that the required initial and continuing training of his department personnel is carried out.
12 years of experience in the same position. • Excellent understanding of the rules and guidance of GMP, GLP. • Excellent know-how of validation, documentation, internal auditing and training. • Strong Leadership and Managerial skills. • Growth Mindset .• Excellent organizational skills and attention to detail. • Strong analytical and problem-solving skills. • Proficient with Microsoft Office