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Quality Assurance Specialist

Il y a 2 mois


Paris, Île-de-France ProductLife Group Temps plein

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.