Junior Officer
Location: Ankleshwar, India
Category: Quality Jobs
Company: Cadila Pharmaceuticals Ltd
Job Code: 18004902
Brand: Manufacturing - Ankleshwar
Job Status: 1
Description:
• Maintain and adhere to GLP and safety procedures in the laboratory.
• Perform analysis as per work allocation and record results in worksheets (protocols) for raw materials, packing materials, intermediates, APIs, stability studies, etc., following current specifications and methods of analysis.
• Work as an analyst and maintain CFR 21 Part-11 compliance by following laid-down procedures.
• Conduct HPLC-related analysis and perform online documentation for in-process, intermediate, finished products, returned goods, raw materials, hold time studies, stability studies, and working standard analysis as per specifications and SOPs. Report analysis data in LIMS modules and to the Section Head or QC Head.
• Ensure that every specification and method of analysis corresponds to the correct product/material code.
• Follow the instructions of the Shift/Section In-Charge for analysis and planning.
• Report QI/NQI/OOS/OOT deviations or discrepancies in laboratory analysis to the QC In-Charge and initiate investigations accordingly.
• Perform calibration of laboratory instruments as per schedule and SOPs, ensuring documentation and updating instrument calibration status tags.
• Record and verify all entries and results to ensure compliance with current specifications and STPs.
• Maintain column performance records and logbooks.
• Properly document instrument logbooks as per analysis requirements.
• Receive training from concerned personnel to update cGMP knowledge and technical expertise.
• Maintain reference, working standard, and impurity standard usage records.
• Keep instrument history records up to date.
• Conduct joint analysis with A.R. laboratory personnel during analytical method transfer on HPLC.
• Prepare stability protocols and reports.
• Perform stability sample analysis as per the stability schedule.
• Monitor and record daily temperature and humidity for refrigerators, working standard chambers, and laboratory areas.
• Conduct holding time studies of intermediates and prepare reports.
• Investigate and report OOS results in raw materials, intermediates, and APIs.
• Ensure CFR 21 Part-11 compliance and follow good chromatography practices during analysis, integration, and review of online and offline chromatographic data to maintain data integrity.
• Prevent spillage of laboratory chemicals and solvents.
• Prepare mobile phase/solutions for analysis as needed to minimize wastage of laboratory chemicals, reagents, and solvents.
• Coordinate with the store department to provide prior information regarding urgent analysis of raw materials.
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Europe | France | Latvia | Lendava | Leuven | Poland | Slovenia | Spain |Finland :
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Canada |Quebec :
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Auckland |New Zealand :
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Madrid |Cebu Province :
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Manila |Croatia :
Croatia |Zagreb :
Zagreb |Estonia :
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