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

Groupe ProductLife; France; Sur place; EUR 45 000 - 60 000; Plein temps

Résumé du poste

Groupe ProductLife recherche un Expert en Assurance Qualité en Pharmacovigilance pour rejoindre son équipe en France. Le candidat idéal aura plus de 8 ans d'expérience dans un rôle qualité au sein de l'industrie pharmaceutique, ainsi qu'une connaissance approfondie des processus de pharmacovigilance. Ce rôle inclut la gestion des non-conformités, la formation des équipes, et le soutien aux audits clients. Une excellente communication en français et en anglais est requise.

Qualifications

• Plus de 8 ans d'expérience dans un rôle qualité dans l'industrie pharmaceutique.
• Connaissance antérieure dans le domaine de la pharmacovigilance.
• Capacité à former le personnel sur les processus qualité.

Responsabilités

• Soutenir l'implémentation du processus de PV dans les équipes opérationnelles.
• Assurer la mise à jour et l'amélioration des SOP.
• Former l'équipe de PV aux processus qualité.

Connaissances

Gestion de procédures spécifiques à un client

Rédaction de procédures

Analyse des écarts

Préparation d'audits

Communication avec le client

Formation

Baccalauréat ou diplôme supérieur dans un domaine scientifique

Outils

QMS (comme ENNOV, Trackwise, Mastercontrol, Veeva)

Outils de modélisation graphique (Visio)

MS Office, Excel, SharePoint

Description du poste

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

France

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Other

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Permanent contract

MAIN ACTIVITIES FOR THE JOB

• Support implementation of PV process in PV operational Teams
• Ensure that SOP are up to date and regularly reviewed for improvement, following a risk based approach and performance improvement objectives
• Ensure that SOP are user friendly and based on visual and graphics (Business process modeling methodology)
• Support continuous improvement to meet compliance goal and company objectives
• Manage non conformance and ensure implementation on time of CAPA plans
• Be the client point of contact for Quality topics when dedicated to a project
• Have oversight on PV NC and CAPA plans, ensure consistency of data, provide reports, support Quality KPI trends analysis and ensure set up of remediation plan when needed
• Train the PV Team to Quality process and use of eQMS
• Support client audits, from team preparation, document preparation, meeting hosting and facilitating, preparation of audit response report
• Act as lead auditor for internal / vendor audit

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)