Provide leadership and strategic direction to Quality oversight of Production, Projects, Supplier Management, operational/quality processes and documentation
To drive and manage site\xe2\x80\x99s Quality Systems to ensure smooth operations and compliance
Ensure Quality Systems are effectively implemented for the site, including but not limited to Deviation, Change control, CAPA, Document control, Training records, Complaints monitoring, Audit readiness, regulatory compliance, and Supplier Management
Develop and maintain Quality Systems documentation and records
Continuously identify and drive improvement initiatives to Quality Systems to achieve business objectives
Provide subject matter expertise on Quality Systems and management in cGMP
Oversee QA Compliance and Audit related activities to ensure safe, efficacious and quality products can be supplied in accordance with regulatory and business requirements.
Manage and ensure product and process quality and compliance throughout the production life cycle.
Collaborates closely with Production, other Quality team, Engineering functions etc
Support the training of personnel on Quality Systems and their workflow and processes.
Establish quality standards and metrics
Engage and collaborate with operation teams to ensure product compliance and timely release of products
Undertake tasks assigned by leaders as and when appropriate
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