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
New Packaging development and routine incoming inspection – 15%
- Work with Asia packaging specialist to develop new packaging suppliers to meet the increased volume and introduced new process/equipment.
- Continuously optimize packaging material to improve the plant’s performance on TDQ and OTIF and ensure the packaging material meet our spec prior to use.
- Collate packaging information to ensure completeness and accuracy in PICASSO and related databases.
Plant GMP / Security Program – 10 %
- 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 – 10%
- Implement Quality requirements (KORE and ISO) and provide suggestions and recommendations for improvement based on food/pharmaceutical industry’s experience.
- Lead the team to play a key role in the implementation, assessment and improvement of Quality and Food Safety Management System
- Support internal auditor team of quality system and actively participate the scheduled internal audit to continuous improve/upgrade plant’s quality system and operations.
Capability – 5 %
- Identify training needs of the associates.
- Responsible to lead midyear/annual performance review, provide feedback and documenting the performance of associates.
QUALIFICATIONS :
- Bachelor or Postgraduate degree in food technology or food science, or biochemistry or relevant qualification suitable for process QA Analyst job
COMPENTENCIES / SKILLS:
- Minimum experience is 4-5 years prior experience in production supervision role in a food/beverage or pharmaceutical industry.
- Familiar with ISO and Food Safety Quality System, understand KORE requirements will be preferred.
- Knowledge of concentrate manufacturing and quality system, project management experience; strong GMP experience, problem solving skills. strategic-thinking, planning, organizing and executing skills. Knowledge of local food laws/regulations.
Travel –
- Travel requirements are in response to problems for the most part and therefore no specifically planned up front. Approximate time is 10%.
Job complexities –
- Able to work in shifts.
- As indicated, the impact is on all manufacturing operations as far as quality is concerned and this applies to warehouse, distribution aspects, Customer Complaints investigation and resolutions.
- Participate in visits to Customers to resolve alleged quality issues with manufacturing. Co-ordinate joint efforts with other CPS plants on quality initiatives and was identified to participate in cross audits with Corporate Quality. Daily contact with the Leadership Team, Wider Management Team and associates throughout the plant.
Skills:
Data Analysis; Pattern Recognition