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

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