Description:

Alliance Biotech Solutions is seeking an experienced QC Microbiology Consultant to support a large-scale method transfer remediation and validation program at a pharmaceutical manufacturing facility. This role will focus on the assessment, remediation, transfer, and validation of legacy microbiological methods to ensure compliance with current GMP requirements and regulatory expectations.

Requirements:

Responsibilities

• Evaluate and remediate legacy microbiological methods.
• Support method transfer and validation activities.
• Author protocols, risk assessments, and reports.
• Review historical data and identify compliance gaps.
• Troubleshoot microbiological methods and support investigations.
• Train analysts and support knowledge transfer activities.
• Generate GMP documentation and final reports.
• Partner with QC and QA teams to ensure regulatory compliance.

Experience/Skills