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

Groupe ProductLife; France; Sur place; EUR 55 000 - 75 000; Plein temps

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

Management of client specific procedures, NC and CAPA

Trainer of OPS staff on Quality process

Writing of procedure and process mapping

Support of GVP audits

Client facing skills

Formation

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

Outils

ENNOV

Trackwise

Mastercontrol

Veeva

Visio

MS Office tools

Description du poste

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

France

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)