Team Member-Quality Control
16 hours ago
Role & responsibilities :-
- Responsible for entry and exit procedure in QC.
- Responsible for GMP/GLP/GDP Compliance.
- Responsible to undergo analyst qualification procedures.
- Perform the analysis by using Analytical Balance Microbalance, pH meter, Conductivity, KF, Autotitrator, Halogen Moisture, UV, IR and Hot air Oven. Etc.
- HPLC and GC Instrumental analysis.
- Release of Raw Materials ,packing materials, In process Intermediate Bulk and finished products as per SLA.
- SAP activities, LIMS and release as and when completes the analysis.
- Making sure disposal of all leftover quantity of analyzed products on daily basis as and when analysis is completed.
- Reporting of on-line incidents, OOS, OOT as per prescribed format and SOP to QA and helping in investigating of root cause along with immediate superior.
- Online analysis and documentation immediately after completion of activity.
- Ensuring housekeeping of laboratory & cleanliness in place.
- Shall be undergone the functional trainings as well as other training.
- Following of safety measures as per the given guidance.
- Ensuring that shift-work is handed-over appropriately to reliever before leaving the lab.
- Review and submission of all completed documents to QA.
- Analytical balance, KF Standardization, pH meter daily performance check and its maintenance.
- Perform Wet Analysis like Water Content, LOD, Heavy Metals, Assay by Potentiometry, SOR and IR Analysis for Raw Material Samples.
- Perform HPLC, GC Analysis for Raw Materials Analysis
- Report any quality concerns or suggestions for improvements to managers.
- Execute all tasks and activities as per the applicable SOPs.
Preferred candidate profile
• Sound knowledge of HPLC, GC Analysis on Chromatography and Wet Analysis
• Knowledge of calibration and performance verification of analytical instruments and equipment as per the master schedule.
• Good understanding of advanced instrumentation technique skills.
• Experience in ensuring the maintenance, preparation, and procurement of laboratory standards, chemicals, and solvents according to established procedures.
• Participation and organization of equipment/instrument qualifications and change control mechanisms.
• Procurement expertise for laboratory requirements.
• Attention to detail and commitment to ensuring compliance with QMS (Quality Management System) documents, including OOS (Out-of-Specification), OOT (Out-of-Trend), and Incident investigations.
• Ability to respond to internal and external audits and participate in other QMS-related activities.
• Strong organizational skills for LIMS (Lab Information Management System) related activities.
• Effective communication and collaboration skills for coordinating and implementing of SOPs.
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