高级质量体系工程师

Work Your Magic with us!
Ready to explore, break barriers, and discover more? We know you’ve got big plans – so do we! Our colleagues across the globe love innovating with science and technology to enrich people’s lives with our solutions in Healthcare, Life Science, and Electronics. Together, we dream big and are passionate about caring for our rich mix of people, customers, patients, and planet. That's why we are always looking for curious minds that see themselves imagining the unimaginable with us.
Your role：
Overall Objectives of the Position ：
The QS Engineer role will entail ensuring compliance with all regulatory and corporate requirements in support of regulatory（ISO, Chinese GMP, EU GMP and applicable agencies）and customer expectations, by carrying out quality management system and quality control tasks and activities.
Conduct internal and external audits of manufacturers, laboratories, supplier, etc. to assure compliance to cGMPs/ISO.
Resolve quality concerns and implement quality improvements with other department Managers, Supervisor to assure current methods, procedures or SOP’s meet current standards.
Comply with company EHS safety regulations and master skill of safety work and emergency rescue knowledge.
Main Tasks：
Develop and implement consistent processes and systems that assure quality, GMP and compliance. The main responsibility includes:
1) Prepare the quality related procedure according to company requirement.
2) Review and approve the SOPs.
3) Prepare the quality related procedure according to company requirement.
4) Follow up the progress of documentation system building up.
5) Build up the quality related electronic systems.
6) Participate in GMP training program in the plant to ensure the training management meeting the requirements of site and global.
Participate in training-need feedback and implement GMP training activities at the factory, enhancing employees' quality awareness and skills.
Responsible for preparing and handling of quality complaints and ensure timely closed loop handling of complaints.
Change control management
Responsible for factory quality certificate declaration cycle management and certificate system maintenance.
Organize customer audits and official certification audits to ensure that the company's quality management system continues to be effective and meets customer requirements and official certification standards.
Responsible for customer audit/ internal GMP/ISO audits and follow up of CAPA’s with internal department and make sure the audit closed in time.
Responsible for communicating external quality related matters to the factory to ensure effective communication and coordination with suppliers, customers and regulatory authorities.
Support for quality related tasks of transferring products from different giving sites to Life Science Nantong.
Complete other quality systems related work assigned by superior.
Be a valuable team member of Quality organization through close teamwork and cross functional/sectional activities.
Actively participate in quality culture building and quality related activities.
Actively report quality related events and participate in continuous quality improvement activities.
Who you are：
Bachelor or above
Minimum 10 years of working experience in pharmaceutical or GMP/ISO environment with some auditing experience.
In-depth knowledge of Quality Systems and related norms (e.g. ICH7/ 8/9/10, ISO 9000 series)
Good experience in product release and Good experience in deviations investigation and root cause analysis.
Experience of E-Quality System like Trackwise, SAP system is preferred.
Experience of lead customer audit is preferred.
Fluent in English. Good reading, writing and communication skills.
New project experience is preferred.
Can work under pressure, handle and overall manage multiple tasks.