Quality Assurance Pharmacist - GMP, CAPA & Compliance

Excelya Group; Boulogne-Billancourt; On-site; EUR 60,000 - 85,000; Full time

Job summary

Excelya in France is seeking a Quality Assurance Pharmacist to strengthen the Quality team and ensure regulatory compliance across the drug development and manufacturing lifecycle. You will oversee QMS documentation, product quality activities, and cross-functional collaboration with Manufacturing, Regulatory Affairs, and Pharmacovigilance.

The role covers deviations, CAPAs, change controls, batch release review, audits, and supplier interactions, plus training programs.

Qualifications

• Strong knowledge of GMP, GDP, GVP and Pharmacovigilance requirements.
• Experience managing Deviations, CAPAs, Change Controls and RCA.
• Experience with Quality Management Systems and tools such as TrackWise, EDMS, SAP.

Responsibilities

• Manage quality documentation including SOPs, procedures, and quality records.
• Coordinate document lifecycle activities: creation, review, approval, archiving, and periodic reviews.
• Participate in internal audits, supplier audits, and health authority inspections.
• Manage quality events including deviations, CAPAs, change controls, and continuous improvement initiatives.
• Review Product Quality Reviews (PQRs) and monitor quality trends.
• Review and approve batch release documentation and distribution-related activities.

Skills

GMP

GDP

GVP

Pharmacovigilance

Education

PharmD (Doctor of Pharmacy)

PRI registration (asset)

Tools

TrackWise

EDMS

SAP

Other QA Systems

Job description

Excelya in France is seeking a Quality Assurance Pharmacist to strengthen the Quality team and ensure regulatory compliance across the drug development and manufacturing lifecycle. You will oversee QMS documentation, product quality activities, and cross-functional collaboration with Manufacturing, Regulatory Affairs, and Pharmacovigilance.

The role covers deviations, CAPAs, change controls, batch release review, audits, and supplier interactions, plus training programs.