QPI Specialist 048

ProductLife Group is looking for a QPI Specialist to join our dynamic team in France.

 

About us

Group 10
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.

Group 13
Profile

We are looking for someone with the following qualities:

Bachelor’s degree or Higher degree in Science related field, or equivalent experience. QA and PV Education

Quality Specialist/Expert with background in both Quality & Pharmacovigilance and experienced in GVP Regulation. Can support facilitation and management of GVP client audits.

Excellent presentation skills and experienced  facilitator.

QPI Specialist 048