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DUTIES AND RESPONSIBILITIES

• Provide guidance to development, operations, laboratories, and validation groups for compliance with quality standards and regulatory requirements such as GMP and GLP.

• Conduct regular reviews and approvals of records, reports, and completed tasks for accuracy and adherence to procedures, ensuring the timely release of tasks.

• Collaborate with development teams during design and prototyping, participating in reviews to ensure products meet quality requirements.

• Support operations teams in implementing and maintaining quality control measures on the production floor through periodic inspections.

• Work closely with laboratory teams to ensure testing protocols and procedures meet quality standards; review and approve laboratory reports for accuracy and compliance.

• Oversee the validation of equipment, processes, and systems, reviewing and approving protocols and reports to ensure regulatory compliance.

• Identify and implement opportunities for process improvements, collaborating with cross-functional teams to enhance the overall quality management system.

• Provide training to employees on quality systems, procedures, and regulatory guidelines. Ensure that all personnel involved in manufacturing and quality processes are aware of their responsibilities.

• Participate in internal and external audits, responding to audit findings and implementing corrective actions especially related to quality control tests, procedures, and laboratory equipment