- Experience in Method Validation and Stability Studies.
- Review of electronic data, audit trails, and backup systems.
- Expertise in qualification and calibration of analytical instruments such as HPLC, GC, ICP-MS, AAS, FTIR, and UV.
- Hands-on experience in ICP-MS operation, troubleshooting, and elemental impurity analysis.
- Review of QC software, analytical data, and laboratory documentation.
- Knowledge of cGMP, GLP, Data Integrity, ICH, and FDA guidelines.
- Investigation of OOS/OOT results and support for audits and regulatory compliance.
Required Skills
- Must be excellent in written and spoken English; net savvy and adept at computer skills.
- Logical thinking.
- Organizing.
- Valuable in communication.