Cps Id-process QA Specialist

**Position Overview**
- 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.

**Responsibilities**

**Process Quality Activities**:

- 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
- Approve 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
- Manage Shelf Life Extention request for Ingredient/beverage bases and liase with all relevant parties for approval
- Support sampling and analysis of ingredient, packaging, in process, finished product including release in SAP if required.

**Plant GMP / Security Program**
- Owning the Plant Inspection program to sustain the GMP/5S Culture.
- Routinely monitoring and adherence to Good Manufacturing Practices of the highest standard and ensure plant’s security program are in-placed effective.
- Follow-up on the execution of the GMP programs in both general facilities by outsourced service contractor and manufacturing area by direct GMP housekeepers
- Management of the pest control and housekeeping program by monitoring & evaluating the service performance (contractors), controlling, and monitoring the housekeepers’ performance inside the manufacturing area to ensure total compliance with GMP standards.

**Management System**
- Lead Quality Management System (ISO-9001) implementation ensuring:

- The quality management system conforms to the requirements of this International Standard
- The processes are delivering their intended outputs; reporting on the performance of the quality management system and on opportunities for improvement,
- in particular to top management; the promotion of customer focus throughout the organization; the integrity of the quality management system is maintained when changes to the quality management system are planned and implemented
- Lead Food safety Management system to manage a food safety team and organize its work, to ensure relevant training and education of the food safety team members, to ensure that the food safety management system is established, implemented, maintained and updated, and to report to the organization's top management on the effectiveness and suitability of the food safety management system
- Lead and organize internal audit system includes scheduling, define internal auditors, conduct refreshing training and evaluate auditor performance.
- Implement Quality requirements (KORE and ISO) and provide suggestions and recommendations for improvement based on food/pharmaceutical industry’s experience.
- Participate and support the implementa