Team Member - Quality Control

Job Summary

We are seeking an associate for the Quality team responsible for conducting sampling and analysis of packaging and raw material samples. The role involves ensuring accuracy in documentation, adherence to safety procedures, reporting discrepancies, and maintaining lab safety.

Roles & Responsibilit

• Responsible for the compliance of cGLP in respective area.
• Responsible for safety compliance in respective area.
• Responsible for maintenance of 5s in the Lab.
• Responsible for Authorized SAP & LIMS Transactions.
•  Responsible for preparation of Method Transfer Protocols & Reports.
• Ensuring SOP compliance in the Laboratory.
• Responsible for analysis of Raw Material, In-process, Finished products, Stability samples, Method validation, Method transfers and Method verification.
• Following the relevant SOPs and STPs during the analysis.
• Follow online documentation practices.
• Verify the analytical results conformity with the specification limit.
• Instrument method and processing method preparations and execution.
• Preparation and Review of sample sets.
• Processing of sample sets and audit trial review.
• Responsible for management of Empower3 software & Audit Trail review.
• Responsible for completion of trainings within the timelines.
• Responsible for initiation and investigation of OOS, Incident and Quality notification.
• Responsible for Authorized SAP transactions.
• Following the online documentation and calculation practices.
• Execution and monitoring of method validation and method transfers.
• Responsible to ensure compliance for all regulatory and country specific queries.
• Verification of Export COA’s and Tech pack documents.
• Responsible for analyzing the method related issues.
• Responsible for preparation and maintenance of Laboratory Analytical Standards.
• Responsible for calibration and performance Verification of instruments.
• Responsible for Approval of documents in LIMS.
• Responsible for Nitrosamines testing and evaluation.

• Responsible for SOP preparations & training coordination from lab and any additional responsibilities assigned by the Group Leader.

Function: Other
Experience Level: Executive