Pharmacovigilance QA Auditor — Brussels, 4 Days/Week

Prothya Biosolutions (operating under Accord Plasma B.V. / Intas Pharmaceuticals); Brussel Hoofdstad; Sur place; EUR 55 000 - 85 000; Plein temps

Avantages offerts par ce poste

Group health insurance

Meal vouchers

Eco-cheques

Flex Reward Plan

Holiday system

Homeworking after onboarding

Résumé du poste

Prothya Biosolutions Belgium is seeking an Auditor QA Pharmaco Vigilance to manage and execute the PV audit program in Brussels, four days a week. You will coordinate internal and external audits, ensure alignment with GVP standards and regulatory requirements, and report findings to the Senior Manager QA Systems Global.

The ideal candidate holds a degree in chemistry, biology, pharmacy or related field, several years in a cGMP environment, and certifications as an auditor.

Qualifications

• Bachelor’s degree in chemistry, biology, pharmacy or related.
• Several years of experience in a cGMP environment.
• Certification as auditor and knowledge of audit methods.
• Experience in training internal/external auditors.
• Strong communication in English and Dutch or French.

Responsabilités

• Management of internal and external Pharmacovigilance audits, both PV and external audits.
• Set up annual PV audit schedules and ensure audits are designed, carried out and managed.
• Assess auditee CAPA plans for completeness, timeliness and accuracy.
• Maintain up-to-date QA SOPs related to PV auditing and ensure alignment with GVP standards.
• Communicate findings and recommendations to cross-functional teams.

Connaissances

Auditing

Analytical skills

Problem solving

Communication

Cross-functional teamwork

English proficiency

Dutch or French

Formation

Bachelor's degree in chemistry

Biology or Pharmacy

Outils

Windows

Word

Excel

Access

Description du poste

Prothya Biosolutions Belgium is seeking an Auditor QA Pharmaco Vigilance to manage and execute the PV audit program in Brussels, four days a week. You will coordinate internal and external audits, ensure alignment with GVP standards and regulatory requirements, and report findings to the Senior Manager QA Systems Global.

The ideal candidate holds a degree in chemistry, biology, pharmacy or related field, several years in a cGMP environment, and certifications as an auditor.