Specialist QC Compliance

About the role

The Specialist QC Compliance acts as a Subject Matter Expert (SME) ensuring that Quality Control processes meet regulatory, cGMP, and site requirements. Working in a fast‑paced biotechnology or pharmaceutical environment, the role drives continuous improvement, safeguards data integrity, and manages quality events.

Key responsibilities

• Oversee, document, investigate and close quality events, including deviations, root‑cause analyses, CAPAs, change controls and periodic reviews.
• Coordinate the QC Data Integrity Plan, perform risk assessments, implement mitigations and deliver data‑integrity training.
• Support qualification and validation of QC equipment and related software (URS, protocols, risk assessments, reports) and track work orders, maintenance and calibration.
• Assist with QC sample management, material release and monthly review of environmental monitoring system alarms.
• Author, review and maintain SOPs and quality documents; participate in audit/inspection readiness and address observations.
• Monitor regulatory and pharmacopoeial updates and coordinate their implementation.

Required profile

• MSc in Biotechnology, Pharmaceuticals, Engineering or equivalent industry experience.
• Minimum 5 years in a GMP environment, with at least 3‑5 years in Quality Control.
• Fluent in French and English (C1 level or equivalent).

Required skills

• Deviations management
• CAPA implementation
• Change Control processes
• Equipment qualification and validation
• Data integrity risk assessment
• LIMS operation
• SOP authoring and maintenance
• Audit/inspection readiness