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2. Participate in preparing for receipt of external audits.
3. Prepare the monthly plan/daily work programs to execute stability analysis according to the department monthly plans, priorities in coordination with the department manager.
4. Initiate and update SOPs relevant to the analytical activities.
5. Obligation to cooperate in the planning and implementation of company-specific quality policies and targets
6. Ensuring that processes needed for the quality management system are established, implemented and maintained,
7. Developing the management review agenda , Coordinating the reporting of results and Publishing minutes of the management review.
8. Responsible for regulatory functions.
9. Maintain regulatory affairs files to support compliance with regulatory requirements.
10.Processing and monitoring registration requirements, including renewal of documentation as necessary.
11.Understanding international compliance trade laws and implementing these laws in company operation.
12.Provide on going support to team for regulatory/compliance issues and questions as per mecomed guidelines.
13.Field action communication and follow-up.
14.Support in filling vendor specific documents (such as quality assessments & agreements, due diligence) upon request.
15.Preparing reports for head office as may be requested.
Requirements and Qualifications:
– B.Sc. degree in Industry Engineering , Pharmacy or any related field .
– From (1-3) years of experience .
– Strong knowledge of ISO 9001 requirements
– Good written, read and spoken Arabic and English Languages
– Demonstrate excellent analytical skills, able to plan, organize and follow up work effectively while focusing on quality towards excellence.
– Strong team player with excellent communication skills
– Proactively take initiatives and demonstrate a dynamic approach to adapt with changing business needs and environment
– Ability to listen and influence
– Ability to summarize information and communicate effectively