Process QA Analyst

Process QA analyst is expected to
• Build a Total Quality Management culture by driving/developing the capabilities of the Associates on Quality aspects on the job and to evaluate process/equipment capabilities through the Validations and Process Monitoring.
• Ensure manufacturing processes/process quality activities are followed in compliance with KORE & ISO, GMP and local regulation requirements by developing & providing SOP’s for plant processes and timely technical support and decision on the quality problem, observation to protect product’s integrity and specification amd final disposition of customer complains/feedback.
• Establish and maintain an effective, governed and documented system for all company processes, which is integrated compliant to its entire applicable standard references and capable of meeting company requirements continually.
• Evaluate new packaging material and ensure the packaging fitness for use and handling of all packing material documentation which is part of quality system.
• Use data analysis tools and analyse data to reach logical conclusion to find out root cause of issues and develop corrective/preventive action plan.

Process Quality Activities: - 60%
• Ensure plant’s operations continue keeping pace with new KORE requirements, regulations, quality management methods and industry best practices.
• Regular conduct the risk assessment for plant key processes to mitigate the risk of failure to deliver Quality product.
• Ensure that quality is built into the process by training Associates on Quality monitoring aspects.
• Validate equipment and processes, routinely monitoring and adherence to Good Manufacturing Practices of the highest standard.
• Create a technical library/database by compiling in an easy retrieval system all the technical information available in the plant post-commissioning and compiling the validation reports generated as a result of the Validation Master Plan implementation.
• Ensure all manufacturing instructions (SMI) are followed by production effectively.
• Organize and support plant’s associates to use the problem solving tools for root-cause analysis and action plans to eliminate the recurrence of quality issue
• Support Corrective/Preventive actions of PDR, TDQ, and analysis of manufacturing problems.
• Perform process validations and process capability studies to ensure the performance of production equipment meet KORE requirements and required actions are implemented if there is any deficiency
• Inspect manufacturing equipment for use after maintenance (calibration, maintenance, etc).
• Assess existing processes/operations to seek the possibility to eliminate non-value activities by adopting OE concept and methodology
• To review the completed analysis report against KO requirements and documents relating to food regulation for auxiliary material / processing aid to authorize the supplier finally
• Conduct SPC and other data analysis of process data