Job Description
We are looking for an experienced QC Analytical professional (6–12 years) with strong exposure to analytical testing, data review, and GMP-compliant quality systems in a biopharmaceutical environment.
Key Responsibilities:
- Review analytical data for DS, DP, stability, method validation, and method transfer samples.
- Perform and review chromatographic and plate-based analytical techniques.
- Manage reference standards, laboratory documentation, calibration activities, and inventory.
- Handle investigations related to Deviations, OOS, OOT, CAPA, and Change Controls.
- Support equipment qualification (IQ/OQ/PQ), analyst qualification, and training activities.
- Ensure compliance with GMP, GLP, and GDP requirements.
Technical Expertise Required:
- CEX-HPLC, SE-HPLC, RP-HPLC
- ELISA, RT-PCR
- Capilla...