Quality Assurance Head At Sandoz Egypt
Job Description
-Lead the Quality Assurance function thereby ensuring that all processes and procedures, tasks, responsibilities and projects are in compliance with all pharmaceutical laws, Quality Manual and Policies as well as Industry Best Practices.
-Comprise special GxP requirements.
-Ensure that all quality relevant processes are compliant and that non-compliance is appropriately addressed via corrective & preventive actions (CAPA) and/or escalation of issues
-Ensure implementation of applicable Quality Standards and governance processes and all regulatory controls are in place in relevant process steps
-Ensure adherence to GxP, any further legal and company internal regulations for manufacturing, control and distribution operations and to HSE guidelines and requirements
-Ensure implementation of defined Key Quality Indicators in the area of responsibility to monitor on an on-going basis that relevant processes are in control and compliant. -Ensure regularly review and assessment of KQIs at the Leadership Team level.
-Ensure adequate escalation of issues and support their timely resolution & provide quality oversight for deviations and adequate corrective and preventive actions (CAPA’s) are implemented.
-Provide quality oversight for planned changes.
-Adequate regulatory inspection preparation, management and follow-up in the area of responsibility.
-Communication with local Health Authorities is adequately shared within the organization and commitments tracked and closed on time.
-Implementation of adequate training within the area of responsibility for all GXP activities by defining, planning and supporting training activities.
-Ensure that processes are in place to communicate country specific requirements to the Region and headquarter organizations for all GXP areas and assess their implications for the compliance of existing processes and systems.
-Initiate remediation activities, as necessary, to ensure ongoing compliance.
-Adequate processing of complaints.
Commitment to Diversity & Inclusion:
Novartis is committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve.
Minimum requirements
-University degree
-Extensive experience in Operation Management and Execution with people management experience
-Sustained Performance & Behavior
-Good understanding of country, regional and local dynamics
-Demonstrated ability to think broadly and innovate within the Pharmaceutical business
-Working knowledge of Pharmaceutical procedures and trends