QC Executive (Reviewer)

Job Summary Responsibilities

• 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.
• Good in communication.

Required Qualification Key Skills

• Reviewer
• Qc