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Job Description
- Ensure that all processes in the lab in accordance with cGMP & 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 & 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 and SFDA.
- Ensure that the appropriate documents which required for registration process in EGYPT and KSA (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 in KSA 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.
Job Requirements
- Bachelor degree of Pharmaceutical science.
- 10+ 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.
