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