Officer - Quality Control
Centrient Pharmaceuticals Netherlands · centrient.com
RupnagarSenior6+ yrs
The job in short
Quality control officer.
Compliance
Details
- Found
- 23 d ago · posted 2020-12-10
- Location as listed
- Rupnagar, Punjab, India
- Role
- Quality Inspector / Technician
- Source
- The company’s own careers site
Full 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.
Quality Inspector / Technician jobs in India · All Centrient Pharmaceuticals Netherlands jobs