Officer - Quality Control

About this role

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

• Post-Graduation in Chemistry.
• Knowledge of cGMP & GLP guidelines, ICH/ USFDA guidelines.
• Working knowledge of Method development and validation.
• Handling of instruments like HPLC/GC/GCHS/Spectrophotometer etc.
• Minimum 6 years of experience in Pharmaceutical industry and extensive Quality control experience in API manufacturing industry.