
QC AMV Officer
2 weeks ago
Role & responsibilities
Develop and validate analytical methods (e.g., HPLC, GC, UV, IR) USP, potentiometer etc.
Knowledge of Chromeleon software
- Prepare and review Analytical Method Validation protocols and reports.
- Conduct method transfer activities to/from contract laboratories or internal departments.
- Ensure timely completion of AMV activities to support product development and regulatory filings.
- Evaluate and troubleshoot analytical methods when required.
- Maintain proper documentation and ensure compliance with GMP and GLP standards.
- Support regulatory inspections and audits by providing necessary documents and explanations related to method validation.
- Collaborate with R&D, QA, and production teams to ensure effective implementation of analytical methods.
Preferred candidate profile
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