Job Summary:
This role involves leading the development and maintenance of quality systems to support organizational objectives.
Key Responsibilities:
* Develop and maintain a comprehensive quality system in compliance with regulatory requirements.
* Manage document control processes to ensure consistency and compliance.
* Represent the quality function at team meetings, providing expert advice and completing documentation reviews in a timely manner.
* Participate in risk management activities to identify and mitigate potential risks.
* Collaborate with technical operations to ensure high-quality product delivery.
* Prepare and present quality metrics to support management decision-making.
* Address customer complaints in accordance with regulatory requirements.
* Implement and manage CAPA systems to address observations and non-conformances.
* Validate computerized systems to ensure compliance with documented procedures and regulations.
* Maintain an internal audit program to ensure audits are completed on schedule.
* Support supplier management activities to ensure adherence to quality system requirements.
* Contribute to continuous improvement initiatives to enhance quality system processes and overall business performance.