Objective-
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.
People Development
NA
KRA's-
- Eliminate customer complaint in shift for any quality/technical reason.
- Eliminate deviations in shift (SAP entry, roll stamping, red card clearance, documentation, GMP practices on shop floor).
- Monitor and devise action plan along with production team to achieve reduction in COPQ as per Business requirement.
- Ensure order processing of customers as per Sales Order and Critical to Quality (CTQ).
- Prepare monthly MIS
