MAIN ACTIVITIES FOR THE JOB

  • 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.

Experience Details:

8 + years’ experience within a Quality role in Pharmaceutical industry + previous role or knowledge in PV domain

Key Skills Required:

  • Management of client specific procedures, NC and CAPA for client
  • Trainer of OPS staff on Quality process (e.g. NC/CAPA)
  • Writing of procedure, process mapping, gap analysis
  • Support of GVP audits
  • Ability to lead working group with clients, take minutes on flight, propose solution
  • Client facing to defend PLG process and find compromises

Required Technical Skills:

  • PV training
  • Quality assurance specific training
  • Experience in using QMS tools (such as ENNOV, Trackwise, Mastercontrol, Veeva etc)
  • knowledge of methodologies such as ISO 9001 2015 standard, Six Sigma, Lean or CMM
  • Graphical process modeling methods and tools (Visio)
  • Skill in MS Office tools, Excel, SharePoint, Content Management tools

Strong Soft Skills:

  • Partnership mindset
  • Commitment to deadlines
  • Excellent written and oral communication skills
  • Communication with client

Required Education:

Bachelor’s or higher graduate degree in a science related field, or equivalent experience

Required Languages:

French + English (Native/Full Proficiency)

QPI Expert (FR) – VAF 166