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Job Description
- Preparing the technical production specifications according to customer requirements.
- Reviewing the technical specifications with the Marketing & Sales Department in case the customer requests any modifications.
- Identifying the training needs of the Quality Department and evaluating the performance of its staff.
- Making decisions in cases of non-conformity that may arise during work, whether related to (Production – Quality – Purchasing).
- Preparing the Quality Manual, procedures, and work instructions related to the factory’s Quality Management System, and reviewing their adequacy as well as the factory’s quality policy.
- Reviewing the quality objectives set by the department managers and ensuring their measurability, alignment with the factory’s quality policy, and commitment to continuous improvement.
- Taking the appropriate decisions to prevent any non-conformities related to products and the Quality Management System.
- Making decisions regarding suppliers based on their annual performance evaluation.
- Approving new suppliers based on testing of the received samples according to the required specifications.
- Defining the necessary measurements during process execution, the monitoring and measuring tools and equipment, and preparing an inventory list of these devices.
- Reviewing and approving the annual calibration plan for laboratory monitoring and measuring equipment, identifying the devices to be calibrated as per the plan, without disrupting workflow.
- Visiting customers with the Marketing & Sales Manager in case of complaints, to investigate potential causes of the complaint.
- Studying customer complaints with the Sales Department, following up on corrective and preventive actions, and ensuring their implementation.
- Preparing the annual internal quality audit plan and appointing a qualified audit team.
- Preparing a report on the execution of the internal quality audit plan.
- Reviewing and approving certificates of analysis for product release after ensuring compliance with technical specifications.
- Reviewing and approving films related to each pharmaceutical product.
Job Requirements
- Minimum of 5 years of experience in quality management within the pharmaceutical, medical device, or related manufacturing industry
- Proven track record of leading quality assurance and quality control teams in a fast-paced environment.
- Strong knowledge of GMP, ISO standards, and other relevant regulatory frameworks.
Demonstrated ability to develop and implement effective quality management systems.
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