general manager quality assurance

To ensure Quality standards and Compliance level at a sterile product manufacturing plant which constantly meets global regulatory requirements including US FDA, MHRA, EU, ANVISA & TGA etc.
To ensure continued site readiness for regulatory and customer inspections.
To ensure that adequate response to the observation(s) is compiled, appropriate CAPAs are identified & implemented in time.
Effective implementation, monitoring and maintenance of the Quality Management System (QMS) by ensuring:
Handling of QMS elements as per the defined procedures meeting regulatory requirements and expectations.
State of control for QMS elements is maintained.
Support for internal audits and to ensure that appropriate CAPAs are identified & implemented in time.
On time compilation of data for quality metrics & trends and implementation of the identified actions.
Timely and effective communication and escalation process exists to raise quality issues to the appropriate levels of management. Timely notifications or escalations to the management or regulatory agency as per the defined procedure.
Handling of the recalled or returned products at site as per the defined procedures.
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