Dawa Limited Quality Management System (QMS) Manager Jobs in Kenya
Dawa Limited Quality Management System (QMS) Manager Jobs in Kenya
As a Quality Management System (QMS) manager having a robust, efficient, and effective QMS is key for a cGMP compliant pharmaceutical operation. The processes for Change Control, deviations and Corrective and Preventive Actions (CAPAs) resulting from the same are in place, needs follow-up, monitoring, facilitation, and organization.
Key responsibilities in the role would involve, but not limited to:
Issue, control, maintain, and archive forms and registers for change control and deviation either in paper, semi-electronic or fully electronic form.
Register, follow-up, and monitor timely close out of all Change Controls and deviations.
Register, follow-up, monitor and verify effective implementation of CAPAs related to deviations, market complaints, recalls, Out-of-Specifications (OOSs).
Organize and invite for Change Control Committee (CCC) meetings for major, complex, or contentious Change Controls and minute the meetings.
Report monthly and trend quarterly Change Controls, deviations, and CAPA closures on an aggregated level.
Participate in investigation teams to find root cause for quality related events such as, deviations and Out-of-Specifications (OOSs).
Perform impact assessment and/ or risk assessment procedure in evaluation of deviations and change control.
Prepare, review, and maintain Standard Operating Procedures (SOPs) related to Change Control, deviation handling and related CAPA handling and to train the same in time.
Ensure all time readiness for audit of the QMS by maintaining highest compliance to established standards and regulatory requirements.
For more information and application details see;Dawa Limited Quality Management System (QMS) Manager Jobs in Kenya
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