Quality Assurance Expert in Pharmacovigilance (French Speaker) – VAF 166

Groupe ProductLife; France; Sur place; EUR 45 000 - 80 000; Plein temps

Résumé du poste

Une entreprise innovante du secteur pharmaceutique recherche un expert en qualité pour diriger le développement et la maintenance de son système de gestion de la qualité. Ce rôle essentiel implique la collaboration avec les équipes de direction pour garantir la conformité aux normes ISO 9001 et l'amélioration continue des processus. Le candidat idéal apportera une expérience significative dans le domaine de la qualité, ainsi qu'une connaissance des outils de gestion de la qualité. Si vous êtes passionné par l'amélioration des processus et la formation des équipes, cette opportunité est faite pour vous.

Qualifications

• 8+ ans d'expérience dans un rôle qualité dans l'industrie pharmaceutique.
• Connaissance des normes ISO 9001 et des méthodologies Six Sigma.

Responsabilités

• Développer et maintenir le système de gestion de la qualité du groupe.
• Fournir une vérification de la qualité et des plans d'action correctifs.
• Gérer les programmes d'audit basés sur les risques.

Connaissances

Gestion des procédures spécifiques aux clients

Formation du personnel OPS sur le processus qualité

Rédaction de procédures

Support des audits GVP

Capacité à diriger des groupes de travail

Relations clients

Formation

Licence ou diplôme supérieur dans un domaine scientifique

Outils

Outils QMS (ENNOV, Trackwise, Mastercontrol, Veeva)

Méthodes de modélisation de processus graphiques (Visio)

Outils MS Office

Description du poste

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.

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).