Summary
Date Posted: Monday, July 25, 2022 , Base Salary: Not Disclosed

JOB DETAILS:

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.



Education Requirement: No Requirements

Job Experience: No Requirements

Work Hours: 8

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