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Associate QA Manager-Beijing
A career at our company is an ongoing journey of discovery: our 57,000 people are shaping how the world lives, works and plays through next generation advancements in healthcare, life science and performance materials. For more than 350 years and across the world we have passionately pursued our curiosity to find novel and vibrant ways of enhancing the lives of others.
Product disposition management:
- Establish and maintain product quality archive; Maintain product list; Complete LEAN SAP system setting correctly and timely to meet the business requirements;
- Perform the goods accept inspection according to local procedure;
- Supervise and ensure the responsible person of importer/3PL to perform the operation as required, verify the problem during goods examination step;
- Product inspection and disposition for the local market;
- Verify the reject product and monitor the handling process to ensure the handing meet requirement of Our company and regulation;
- Translate and archive site CoA of chemical drug;
- Import QC re-test support, including reference standards and lab material supply and management;
- Monitor implementation of the drug traceability system;
- Guide and monitor the quality management of steps: purchase, storage, maintenance, sale, return, transportation etc.;
Primary distribution management:
- Evaluate the shipping temperature data of temperature sensitive products and keep the product under appropriate status
- Implement monthly RFT (Right First Time) review meetings with DHL to analysis, monitor and improve RFT performance
- Track the destructions due to deviation of primary distribution and set up baseline.
Secondary distribution management:
- Supervise the product transportation which was performed by SNO and forwarder to ensure meet requirement of Our company and regulation;
- Local shipping routes management, ensure all used shipping routes be approved;
- Coordinate the concurrent shipping route validations actions to push them are completed according to 2020 VMP (both in summer and winter), ensure the validation meet requirement of Our company and regulation;
- Implement shipping temperature data monthly review and make CAPA if needed to ensure continuous improvement;
- Improve and perform shipping temperature data review plan for the shipment by importer/3PL and distributors to ensure meet requirement of Our company and regulation;
- Organize the regular communication and on-site inspection to importer/3PL and forwarder with SNO to ensure their operation meet requirement of Our company and regulation;
- Update KPI with SNO to ensure KPI meet both global and local business requirements.
- Monitor KPI and set up follow up action list to ensure continuous improvement.
- Ensure the validation and calibration of the importer/3PL and forwarder meet requirement of Our company and regulation;
PQS and Projects:
- Establish and update quality operation related SOP/WI;
- Deviation management and training of deviation and investigation;
- Product recall management and organize mock recall;
- Responsible for handling QO related Alert;
- Support LEAN QM Module phase 2 development project
- DTP(Direct to Patient Pharmacy ) project supporting;
Who you are:
• Licensed Pharmacist (Mandatory)
• Bachelor degree or above in pharmacy, biology, chemistry or related majors.
• At least 5 years working experiences in drug manufacture and/or distribution area
• Experience of working in QA area in multinational companies is preferred
• Fluent English in listening, speaking, reading, and writing.
• Be familiar with SAP operation and logistic
PROFESSIONAL & TECHNICAL SKILLS
• Good communication skills
• Professional knowledge in GDP(GSP)/GMP
• Problem solving ability and skill
• Ability to face challenge and self-learning
Functional Area: Quality
What we offer: With us, there are always opportunities to break new ground. We empower you to fulfil your ambitions, and our diverse businesses offer various career moves to seek new horizons. We trust you with responsibility early on and support you to draw your own career map that is responsive to your aspirations and priorities in life. Join us and bring your curiosity to life!
Curious? Apply and find more information at https://jobs.vibrantm.com