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
- Bachelor's degree in Microbiology, Biology, Biochemis...