Senior QA Specialist: External QC & GMP Oversight

Recordati; Nanterre; Sur place; EUR 70 000 - 90 000; Plein temps

Résumé du poste

Recordati is looking for a Quality Assurance Specialist in Nanterre to provide oversight of Quality Control activities within the External Supply Organization.

The ideal candidate will have over 8 years of GMP experience and a strong understanding of QC processes, including regulatory inspections. This role requires collaboration with internal and external partners to maintain high product quality and compliance.

You will be expected to lead audits, manage quality events, and drive continuous improvement initiatives.

Qualifications

• 8+ years GMP QC/QA experience with external manufacturing exposure.
• Strong expertise in GMP Quality Assurance and Quality Control.
• In-depth knowledge of QC processes: OOS/OOT/OOE investigations.

Responsabilités

• Provide QA oversight for all QC activities performed by External Supply Organizations.
• Oversee QC investigations ensuring proper documentation.
• Contribute to APQR/PQR programs in collaboration with external partners.

Connaissances

GMP QC/QA experience

GMP Quality Assurance

Quality Control processes

Data integrity principles

Analytical method lifecycle management

Regulatory inspection support

Formation

Master’s degree (MSc), PharmD, or Engineering degree

Description du poste

Recordati is looking for a Quality Assurance Specialist in Nanterre to provide oversight of Quality Control activities within the External Supply Organization.

The ideal candidate will have over 8 years of GMP experience and a strong understanding of QC processes, including regulatory inspections. This role requires collaboration with internal and external partners to maintain high product quality and compliance.

You will be expected to lead audits, manage quality events, and drive continuous improvement initiatives.