QC Analyst – Biosimilar

About the role

The QC Analyst will perform physicochemical, microbiological and biological testing on raw materials, in‑process intermediates, finished products and packaging to guarantee the quality of biosimilar medicines. The role supports laboratory operations through accurate testing, proper documentation and strict adherence to GMP and data‑integrity standards.

Key responsibilities

• Execute analytical tests (HPLC, GC, UV, ELISA, microbiological assays) following SOPs and validated methods.
• Verify results against specifications, flag Out‑of‑Specification (OOS) and Out‑of‑Trend (OOT) findings.
• Maintain, calibrate and qualify laboratory instruments; report any malfunctions.
• Prepare complete laboratory records, analytical reports and ensure ALCOA+ data integrity.
• Support quality investigations, CAPA activities and method transfer projects under supervision.
• Participate in internal audits and external inspections.

Required profile

• Bachelor’s to Master’s degree in Pharmacy, Biotechnology, Analytical Chemistry, Pharmaceutical Sciences or related field.
• 1‑3 years of experience in a pharmaceutical or biotech laboratory, preferably with biosimilars.
• Fluent French; basic technical English for reading protocols and SOPs.
• Strong attention to detail, procedural discipline and ability to work in a team.

Required skills

• Proficiency with HPLC, GC, UV spectroscopy, ELISA and microbiological testing.
• Knowledge of GMP/GxP environments and laboratory documentation practices.
• Understanding of analytical method validation and equipment qualification (IQ/OQ/PQ).
• Ability to ensure data integrity following ALCOA+ principles.