Officer - Quality Control

Centrient Pharmaceuticals; Rupnagar; On-site; INR 1,200,000 - 1,800,000; Full time

Job summary

Centrient Pharmaceuticals is seeking an experienced analytical professional to ensure products meet customer specs and pharmacopoeial standards. You will perform finished product, raw material, and in-process analyses, and support stability studies in line with cGMP/GLP/ICH/USFDA guidelines.

You will calibrate HPLC systems, conduct method development and validation, and manage reagents and instruments to support Premix analysis. Strong documentation and CAPA handling are essential.

Qualifications

• Post-Graduation in Chemistry is required.
• Knowledge of cGMP & GLP guidelines, ICH/USFDA guidelines.
• Working knowledge of method development and validation.
• Handling of instruments like HPLC/GC/Spectrophotometer.

Responsibilities

• Analysis of Finished products / raw materials / in process & stability samples (Wet & Instrumental analysis).
• Calibration of HPLCs as per defined procedure and schedule.
• Method validations as per applicable guidelines.
• Reporting of deviations in analysis and CAPA implementation.
• Troubleshooting of instruments to ensure smooth analytical work.

Skills

cGMP/GLP

ICH/USFDA

Method development

Instrument troubleshooting

Education

Post-Graduation in Chemistry

Tools

HPLC

GC

Spectrophotometer

Job description

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