Team Member-Quality Control

Role & responsibilities

1. Responsible for entry and exit procedure in QC.
2. Responsible for GMP/GLP/GDP Compliance.
3. Responsible to undergo analyst qualification procedures.
4. Perform the analysis by using Analytical Balance Microbalance, pH meter, Conductivity, KF, Autotitrator, Halogen Moisture, UV, IR and Hot air Oven. Etc.
5. HPLC and GC Instrumental analysis.
6. Release of Raw Materials ,packing materials, In process Intermediate Bulk and finished products as per SLA.
7. SAP activities, LIMS and release as and when completes the analysis.
8. Making sure disposal of all leftover quantity of analyzed products on daily basis as and when analysis is completed.
9. 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.
10. Online analysis and documentation immediately after completion of activity.
11. Ensuring housekeeping of laboratory & cleanliness in place.
12. Shall be undergone the functional trainings as well as other training.
13. Following of safety measures as per the given guidance.
14. Ensuring that shift-work is handed-over appropriately to reliever before leaving the lab.
15. Review and submission of all completed documents to QA.
16. Analytical balance, KF Standardization, pH meter daily performance check and its maintenance.
17. Perform Wet Analysis like Water Content, LOD, Heavy Metals, Assay by Potentiometry, SOR and IR Analysis for Raw Material Samples.
18. Perform HPLC, GC Analysis for Raw Materials Analysis
19. Report any quality concerns or suggestions for improvements to managers.
20. 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.