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.
The following information aims to provide potential candidates with a better understanding of the requirements for this role.
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 reg...