| Job Location | Riyadh, Saudi Arabia |
| Education | Bachelor's degree / higher diploma |
| Salary | Not Mentioned |
| Industry | Pharmaceutical Manufacturing |
| Functional Area | Not Mentioned |
Validation and Calibration Department is responsible to cover the activities that may impact the quality of the product and establishing documented evidence through a prospective plan, which demonstrates the compliance of the equipment/systems/instruments with cGMPs, by implementing the proper calibration activities for all related equipment/instruments as required. In addition, the Validation and Calibration Department is also responsible to ensure the compliance of the HVAC system and machines performance qualification in parallel with other related departments. The following activities are covered: Equipment/System/Instrument Performance Qualification. HVAC System and Facility Qualification. Purified Water/WFI Units and distribution loop Validation. Calibration of equipment and instrumentals. Thermal Mapping Studies Job Objectives 1. Prepare and implement the HVAC systems protocols and reports, and ensure of the compliance of the HVAC system as per the cGMP. 2. Setting goals for performance and deadlines in ways that comply with related standard procedures. 3. Organizing workflow and ensuring that staff understand their duties and delegated tasks. 4. Monitoring staff productivity and providing constructive feedback. 5. Prepare the departmental KPI. Roles and Responsibilities:1. Supervising, monitoring, communicating and coordinating of the Validation and Calibration activities and follow-up the departmental plans on the related activities to ensure that all activities are implemented as intended. 2. Prepare, review, and ensure of implementing the planned protocols and reports. 3. Prepare and review the planned validation protocols and reports that are related to the HVAC system (AHU?s and rooms qualification studies) and review the related procedures, and to ensure the systems ability of operate consistently, and issue the annual monitoring reports related to the HVAC system tests. 4. Perform risk assessment for the existing equipment and systems in order to identify the potential risks and accordingly plan the appropriate measure to address the risk factors. 5. Contribute to the internal audits as scheduled and prepare the audit reports as intended. 6. Issue the validation and calibration procedures and ensure that procedures are updated and compliant with the cGMP, related regulations, and guidelines. 7. Ensure performing the planned Mapping studies, and review the reports related to the temperature and relative humidity studies. 8. Ensure of implementing the production rooms Air Balance and other frequent related tests. 9. Follow up on the work requests and tracking of the changes in the systems
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