QC Microbiology Consultant – Biologics (Slovenia)

About the role

This senior, hands‑on consultancy supports a global pharmaceutical organization in preparing its QC microbiology laboratory for regulatory inspections. Based in Slovenia, the consultant will work on‑site with occasional remote flexibility to assess compliance and drive remediation.

Key responsibilities

• Assess the current compliance status of the QC microbiology laboratory.
• Identify gaps and develop practical remediation recommendations.
• Support regulatory inspection and audit readiness, including audit responses, deviations, investigations and CAPAs.
• Review microbiological testing of raw materials, in‑process samples and final biologic products.
• Evaluate environmental‑monitoring processes, laboratory controls, SOPs, training records and controlled documentation.
• Recommend improvements to laboratory workflows and quality systems.
• Provide microbiological expertise to Quality, Manufacturing and Regulatory teams.

Required profile

• Previous leadership of a GMP‑regulated QC microbiology laboratory.
• Direct experience in large‑molecule, biologics, biopharmaceutical or biosimilar manufacturing.
• Strong knowledge of cGMP, GLP and EU/FDA regulatory expectations.
• Proven experience preparing laboratories for health‑authority inspections.
• Relevant degree in Microbiology, Biotechnology, Pharmacy or a related discipline.
• EU/EEA/Swiss nationality or unrestricted work permission in Slovenia.

Required skills

• GMP‑regulated QC microbiology operations
• cGMP and GLP compliance
• EU/FDA regulatory standards
• Environmental monitoring and contamination control
• Microbiological testing of raw materials and biologics
• SOP development and documentation control