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Quality Assurance Specialist
Il y a 2 mois
QPI Specialist 048
ProductLife Group seeks a seasoned Quality Assurance Specialist to drive quality excellence in France.
About us
ProductLife Group is a dynamic company looking for a Quality Assurance Specialist to join our team.
Responsibilities
- Collaborate 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 requirements 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.