Department: Quality Control Analytical Role: QC (Molecular Biology)
Role Summary: As a QC Analytical person, the role involves managing samples from receipt to release, ensuring timely analysis and accurate documentation in compliance with GMP/GLP standards. Responsibilities include performing analytical testing, compiling results, and supporting equipment qualification, calibration, and maintenance. The position also requires participation in stability studies, handling deviations and corrective actions, and maintaining training and regulatory records. Additionally, the role supports audit readiness, SOP development, and continuous improvement initiatives to uphold quality systems and regulatory compliance.
Key Responsibilities: Responsible for Sample management activities, including sample in/out, Entry/Exit of samples, Test sample requests, and management of sample request forms, as well as monitoring analysis status and results for all assigned projects in QC analytical. Responsible for analysis of samples, following test methods, generation and compilation of results, data packets preparation, and submission for review of results in a timely manner. Responsible for performing approved work schedules and emergency work requests into action-oriented plans. Must be able to work after hours, any shifts and weekends and shutdown project(s) as required. Provide emergency response to electrical/calibration issues in Instruments. Responsible for completing performance qualification, performance verification, Performance maintenance, and calibration of equipment and instruments promptly in the QC analytical lab. Responsible for supporting the generation and implementation of quality systems (deviations, change controls, etc.) and assisting in the development and maintenance of applicable standard operating procedures and related systems for congruent management and coordination of stability activities Responsible for writing DRS (Data Recording Sheet), Recording electronic data, archiving raw data, and following GDP procedures as per quality procedures. Responsible for maintaining and Training records for the QC analytical laboratory in accordance with GLP compliance and any other work assigned by the Supervisor or Head of Department. Responsible for initiation of stability studies for drug substance and drug product, maintain stability equipment, perform stability pulls, coordinate sample preparation/submission and testing.
Basic Requirements: Qualification: Master’s degree in science Good verbal and email communication skills Attention to detail and strong compliance mindset Familiarity with GMP and various regulatory guidelines for drug manufacturing Curiosity to read, learn and working across cross-functional teams Basic MS Office: Word, Excel, PowerPoint
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