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Job Description

The Quality Control Manager translates the long-term goals for Quality Control (QC) into Tactical Plans while maintaining oversight of the department's operational and financial status. Sector: Biopharmaceuticals Manufacturing (Enzymes – Probiotics and etc.) ● He/She endorses the Protocols, Standard Operating Procedures (SOPs), Working Instructions (WIs) and reviews Analytical Method Development (AMD) and Analytical Method Validation (AMV) and ensuring alignment with Current Good Laboratory Practices (GLPs). ● He/She defines the analytical data and information required for new product registrations and facilitates the batch release process of biopharmaceutical products by accelerating the compilation of Batch Control Records (BCRs). ● He/She is responsible for building department personnel capability by initiating training programs and developing strategies to facilitate operational improvements for the department. The Quality Control Manager is responsible for all QC activities within the organization. ● He/She is therefore required to have deep knowledge of QC and expertise pertaining to verification of product and process quality for product release. The Quality Control Manager is a leader who provides clear guidance on critical work activities and deliverables and has the foresight to develop skills and capabilities within and beyond the department to optimize resources, talent, and overall performance. Critical work and functions and key tasks: ● Review and endorse Standard Operating Procedures (SOPs) and plans, ensuring alignment with Good Laboratory Practices (GLPs) requirements and the organization’s policies. ● Devise an operational excellence model for validation of Analytical Methods and Procedures. ● Oversee investigations into OOS – OOT to aid the determination of root causes and active participation in Root Cause Analysis (RCA) in accompany with QA. ● Evaluate the impact of analytical process deviations and the need for Corrective and Preventative Actions (CAPAs). ● Review product and process quality metric reports and active participation in PQR (Product Quality Review). ● Facilitate registration and release of biopharmaceutical products in collaboration with Sales, planning - Warehouses, SCM, R & D, Production, QA, and Regulatory Affairs Departments. ● Implement Data Integrity (ALCOA+) in QC Lab. ● Endorse Certificates of Analysis (COAs) and Plan to perform Stability Testing in accordance with ICH Guidelines. ● Approve batches for forwarding processing. ● Liaise with stakeholders in the event of major product quality deviations and product recalls. ● Introduce additional training programs to address gaps identified from audits and inspections. ● Develop strategies for the QC department to encourage continuous improvement of QC procedures, activities, and workflow management. ● Recommend changes to resources, procedures, systems, equipment, and technology within the QC department. ● Monitor effectiveness of improvements and changes made to QC activities and workflows (both in terms of Hardware and Software). ● Communicate, cascade, and implement QC strategies, objectives, policies, and processes to tactical and operational layers of the department. ● Translate the long-term goals of the organization for the QC department into Tactical Plans. ● Set and communicate individual objectives and KPIs and review and assess the performance of direct reports. ● Direct capability development roadmaps and programs for the QC department. ● Coordinate department resources to ensure adequate staffing and capability levels. ● Maintain oversight of the completion of all QC tasks, ensuring proper documentation, progress tracking, and reporting. ● Monitor the QC department's financial inflows and outflows against allocated budgets and forecasts.