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Quality Assurance Expert in Pharmacovigilance (French Speaker) – VAF 166
Résumé du poste
A leading pharmaceutical company is looking for a Quality Assurance Expert in Pharmacovigilance. The candidate should have over 8 years of experience in quality roles within the pharmaceutical industry, with strong skills in client management and training. Fluency in both French and English is required. This role offers a permanent contract based in Auvergne-Rhône-Alpes, France.
Qualifications
- 8+ years of experience within a Quality role in Pharmaceutical industry.
- Experience in pharmacovigilance is a plus.
- Fluent in French and English.
Responsabilités
- Support implementation of PV process.
- Manage non-conformance and CAPA plans.
- Train the PV Team on Quality process.
Connaissances
Formation
Outils
France
Permanent contract
- 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
8 + years’ experience within a Quality role in Pharmaceutical industry + previous role or knowledge in PV domain
- 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
- 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
- Partnership mindset
- Commitment to deadlines
- Excellent written and oral communication skills
- Communication with client
Bachelor’s or higher graduate degree in a science related field, or equivalent experience
French + English (Native/Full Proficiency)
* Le salaire de référence se base sur les salaires cibles des leaders du marché dans leurs secteurs correspondants. Il vise à servir de guide pour aider les membres Premium à évaluer les postes vacants et contribuer aux négociations salariales. Le salaire de référence n’est pas fourni directement par l’entreprise et peut pourrait être beaucoup plus élevé ou plus bas.