Officer - Quality Control

Position Description :

Position ensures that the products provided to the market are tested as per customer specifications and in compliance with applicable pharmacopoeias as well cGMP / GLP / ICH / USFDA / ISO guidelines.

Key Responsibilities :

• Analysis of Finished products / raw materials / in process & stability samples (Wet & Instrumental analysis).
• Preparing stability trend and then sharing with all stake holders.
• Conducting LSC to update all stake holders on stability status.
• Calibration of HPLCs as per defined procedure and schedule.
• Method validations as per applicable guidelines.
• Inventory management of reagents / columns spares etc. required for Premix analysis.
• Mobile phase preparation and their record keeping.
• Printing and preparation of record of analysis.
• Log books management for various activities.
• Preparation / Revision of method of analysis.
• Revision / Preparation of specifications in consultation with Purchase and other departments.
• Reporting of deviations in analysis as per LIR procedure and implementation of CAPA.
• Day to day handling of hurdles for smooth analytical work (Trouble shooting of instruments).
• To ensure good housekeeping in the working area as well as in surroundings.
• Conducting of stability studies of Premix for validation batches / Annual batches.
• To ensure compliance to all SHE guidelines and to ensure safe working.

Requirements