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Quality Assurance Manager

2025-09-15

Role Purpose: ● To ensure all the finished products released from site are fully in compliance with RB requirement and national standards. ● Proactively work on the issues & gaps in manufacturing area and ensure the compliance to reduce product quality risks. ● Lead site validation master plan and manage all kinds of validation activities, including 3Q(HVAC, water system, production equipment etc.), PV and CV. And ensure all validation activities are complied with Reckitt policy and GMP requirement. Lead deviation investigations and CAPA in all validation activities. ● To make sure site validation master plan implemented in time and guarantee all type of projects validated properly by following Reckitt validation policies, SOPs, Reckitt global product development manual, global product quality manual, risk management manual, and technical transfer manual etc. ● To support the WCM project. Scope: ● All the products manufactured in RB(Suzhou) Co., Ltd. ● Project quality management. ● All the quality issues and continuous improvement in mixing and Packaging area. ● Finished goods release. ● Site Validation activity (including Jueding project validation). Accountabilities: 1. Comply with regulations pertaining to disinfectant products, cosmetics, medical devices, as well as the company's quality management system documents. Ensure that the work performed in this position meets GMP requirements and fulfill the obligations related to product quality and safety as outlined in the relevant quality management documents. 2. In charge of projects quality management including NPD/EPD, Squeeze, X-Trim and green/brown project with change control raised, proper impact assessment and implementation action. 3. Monitor the CC status related with projects and validation and ensure they are closed in a timely manner. 4. Ensure the technology transfer process are well followed for NPD, EPD and Sourcing change projects. 5. To ensure all pFMEA are properly conducted for all types of projects in Taicang site, continuously track the risk level and mitigation action status, communicate project progress/challenges/risks from quality POV to different level of management team. 6. Responsible for all quality issues investigation and robust CAPA in production area to prevent quality issue recurrence by coordinating cross functional team resource, share the trend to key stakeholders regularly. 7. To ensure AQL team daily onsite checking and report about production area activities are in compliance with SOPs/WI/compliance requirement. Escalate medium/high severity issues to line manager immediately. 8. Lead the quality agreement based on project’s needs, approve the packaging specification ensure the packaging specification are in consistent with quality agreement. 9. To issue the GFS for NPD/EPD/Sourcing change projects and update the global GFS tracker. 10. Responsible for timely release of finished goods in SAP system and make release/rejection decision when there is deviation or gap. 11. Prepare site validation master plan and ensure all type of validation activities in Taicang completed in a timely manner by following Reckitt policy or regulation, such as Facilities and Utilities validation, Product and Process validation, Cleaning Validation, Method validation, Computerized system validation etc. 12. Lead the quality issue found during projects validation, provide the solution and improvement. 13. Monthly global KPI update. 14. Responsible for drafting the SOP/WI related with project quality management and validation. 15. CPBOM approval and review the BOM, MOM, Spec accuracy for quality manager’s approval. 16. People training and development. 17. Other tasks assigned by line manager. Skills & Experience required: ● Bachelor’s degree or above in Chemistry Engineering, Applied Chemistry, Food or Pharma related. ● Familiar with relevant laws and regulations of disinfectants, cosmetics and medical device, JJF 1070, AQL classification, GB2828. ● At least 5 years’ experience in management field of quality. ● Entrepreneurial decision-making skills and communication skills. ● Strong target orientation and highly motivated. ● People management- Proven experience in leading and developing teams, able to effectively influence people of all levels to drive change and improvement. ● Flexibility in thinking and pragmatic problem-solving skills.


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