Specific activities and responsibilities:
- Collaboration with Head of Quality and Process Improvement to support ongoing development, implementation and maintenance of the corporate quality system.
- Develop and maintain the ProductLife Group quality management system, including requirement for obtaining ISO 9001 certification, with ongoing alignment with the corporate quality management system
- Recommend, develop and maintain the controlled document system, including SOPs, WPDs and any associated forms and templates.
- Ensure data in Quality trackers / system are accurate, up to date and entered in a timely manner, to enable automated reporting.
- Identify process efficiency/effectiveness issues and provide solutions for improvement.
- Maintain a strong working knowledge of SOPs as well as ICH, GCP, local regulations and guidelines.
- Provide quality verification and oversight including corrective action plans for activities not meeting quality standards.
- Provide interpretation and relay to the Managers the need for continuous improvement of processes.
- Management and implementation of ProductLife Group annual risk based audit program (occasional travel)
- Management of internal and client audit and inspection findings.
- Act as the key point of contact for client auditors and vendors PLG audits.
- Support and maintain quality activities for oversight of vendors, suppliers and subcontractors to ensure they are functioning appropriately and audit as required.
- Oversee, maintain and improve training programs within ProductLife Group.
- Work with the departments to develop guidelines and metrics to assure quality and compliant deliverables.
- Quality representative at Global Quality Management Team meetings (occasional travel).
- Collaborate effectively with other managers.