To maintain Quality standards in manufacturing as per customer requirements by implementing all Quality processes.
• Primary responsibilities
Strategic and planning
• Ensure compliance of CTQ requirements in order to eliminate repeat complaints from customers.
Core Functional
Core
• Conduct testing of material as per Quality Plan and assign and inform Quality Status to Production.
• Analyse of product/process non-conformity along with concerned production team to find out root cause of the issue.
• Adhere compliance to all laid down SoP’s and Work Instructions as per cGMP, ISO, and other systems in QA lab.
• Analysis of internal and external customer quality issues.
• Maintain all equipment of QA lab are in working conditions.
Internal Processes
• Prepare reagents for testing wherever necessary and keep checking the strength of reagents/material at regular intervals.
• Sampling of semi-finished products & slit reels as per sampling plans, conduct analysis as per quality plans, work instructions and share results with concerned department.
• Communicate deviations as per laid down systems.
• Ensures all the reagents/counter samples (Retention) are label with relevant details.
• Maintain records and samples in a systematic way for early retrieval and traceability.
• Prepare Monthly Information System (MIS) report for the deviations observed along with the action plan which includes the CAPA effectiveness submitted against the internal/external rejections/complaints during execution of respective customer orders.