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Officer - Quality Control

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LocationRupnagar, Punjab, India
Work modeon-site
Typefull-time
SeniorityMid
Experience6+ yrs
DepartmentQuality
Company size1,001–5,000 people
PostedDec 10, 2020 · 5y ago
Verified live1d ago
May no longer be actively hiring
Posted by the company on Dec 10, 202041% of this company's open roles have been listed for 90+ days
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At a glanceSummarised by Seekless from the posting.
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
Skills
HPLC
GC
GCHS
Spectrophotometer
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:
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Analysis of Finished products / raw materials/ in process & stability samples (Wet & Instrumental analysis).
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Preparing stability trend and then sharing with all stake holders.
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Conducting LSC to update all stake holders on stability status.
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Calibration of HPLCs as per defined procedure and schedule.
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Method validations as per applicable guidelines.
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Inventory management of reagents/columns spares etc. required for Premix analysis.
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Mobile phase preparation and their record keeping.
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Printing and preparation of record of analysis.
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Log books management for various activities.
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Preparation/Revision of method of analysis.
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Revision/Preparation of specifications in consultation with Purchase and other departments.
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Reporting of deviations in analysis as per LIR procedure and implementation of CAPA.
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Day to day handling of hurdles for smooth analytical work (Trouble shooting of instruments).
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To ensure good housekeeping in the working area as well as in surroundings.
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Conducting of stability studies of Premix for validation batches/Annual batches.
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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.