- Preparing the requirements of the quality management systems in the factory (GMP requirements and ISO system).
- Preparing a plan for internal auditing of all departments, coordinating internal auditing activities (and taking part in internal audits), and then reviewing the corrective/preventive action requests and following up on implementation of the corrections.
- Preparing internal audit report & management representative report.
- Preparing the management review agenda, writing meeting minutes and final report.
- Follow up on QMS requirements in all departments (quality objectives, KPIs, customer satisfaction, etc.).
- Issue and follow-up change control action plan.
- Investigate product OOS, OOT, and deviations.
- Investigate customer complaints.
- Follow up on CAPA execution and effectiveness.
- Member of risk assessment team.
- Conducting external audits (Supplier audit).
B.Sc. of Pharmacy or Science.Not less than 3 years of experience in a Non-Sterile pharmaceutical field.Good understanding of the rules and guidance of ISO, GMP and GDP.Good English language.Good Computer skills.Excellent communication skills.Integrity and professional ethics.Attention to detail