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Quality Associate Director
A career at our company is an ongoing journey of discovery: our 52,000 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.
Overall Objectives of the Position
• Lead the implementation of Quality and Compliance system on whole supply chain,
• ensure manufacture processes and products comply with all efficacy, safety and regulatory requirement, identified gaps and keep continuously improve.
• Lead quality departments routine business, include QA, QC, Supplier Auditing and Validation
• Develop the Quality strategy for the project and site together with APAC quality head
• Design, recruit and manage QA/QC organization for the project and the site start up.
• Responsible for all validation activities for the project and the site start up.
1.Develop validation strategy for the project including change management and deviation management
2.Develop and lead the execution of Validation Master Plan
3.Lead or review all project related validation activities including User Requirement Specification, System Impact Analysis, Design Qualification, Risk Analysis, Factory Acceptance Test, Site Acceptance Test, Installation Qualification, Operational Qualification, Performance Qualification, Process Qualification, Cleaning Qualification. QC test methods transfer and validation
4.Design and Approval of Validation protocol and report
5.Liaison with the responsible QA units
• Ensure during project Engineering Design phases quality requirement are met in building, facility, equipment
• Develop QC lab and Quality related area design (having consultation with the experts)
1.Develop method transfer plan and test validation plan for 3 product families
2.Execute method transfer and test validation for all incoming , in-process and final release tests
• Arrange Ensuring the compliance with global and local regulations during project phase and operation phase
1.Meeting global guideline
2.Meeting China regulations for China market and worldwide regulations for export countries
3.Receiving the audit by the authorities and customers
• Responsible for acquiring all related ISO certificates and GMP license with the support of regulatory affair
• Monitor project schedule from quality aspect, report the deviation to project director and propose counter actions, be responsible for execution
• Responsible for Supplier quality management with China procurement for materials qualification and supplier audits
Who you are:
Education and Qualification Required
• Education: Bachelor or above.
• Working Experience:
1.10 years+ experience in quality assurance in Chemistry Pharmaceutical, or equivalent field
2.Experience of QA/QC manager
3.Project (multi-function team) leading
• Technical & Professional Knowledge:
• Quality Management (ISO 9001/GXP):
• Regulatory requirements for chemical handling
• EHS (basic knowledge)
• Team Leading skill: strong team building
• Project management skill: : interpreting internal & external challenges and recommends best practice for the success of the project. Require experience in plant start up and technology transfer.
• Auditor for QMS (ISO 9001 or GXP): professional auditor skill to assess the QMS status and propose the best solutions for the improvement.
• Analytical skills: can utilize effective technical skills having broader perspective of the project to find the best solution
• Problem solving skill: solve complex problems based on sophisticated analytical thought and complex judgement basing on in-depth professional knowledge on Quality and operation.
• Fluent in English
Functional Area: Quality
What we offer: At our company, 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