Job Description
Description:
Alliance Biotech Solutions is seeking an experienced Analytical Chemistry SME 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 analytical methods to ensure compliance with current GMP requirements and regulatory expectations.
Requirements: Evaluate and remediate legacy analytical methods and supporting documentation.
Support method transfer and validation activities.
Author protocols, risk assessments, and technical reports.
Review historical data and identify documentation or compliance gaps.
Troubleshoot analytical 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
Bachelors degree...