Senior Specialist, QA System

6 months ago


Wuhan, China CSL Full time

Responsibilities:
• Under general supervision, maintains Quality Assurance System to ensure compliance with company and cGMP standards
• Responsible for regulatory authority inspections and external customer audit management, including inspection preparation, establish inspection support team, CAPA response submission
• Supplier audit and qualification management, including supplier performance review, approved supplier list & approved material list management, supplier audit schedule development and audit implementation, quality agreement management
• Self-inspection management, including self-inspection plan development and implementation, follow up the execution of CAPAs to the observations in self-inspection

• Manage the quality review of plasma center, including the on-site audit of critical materials in plasma center

• CAPA management and eQMS management, oversight the whole CAPA process, monitoring the CAPA KPIs, make sure CAPA are managed in an efficiency way

​• Regulation monitoring, organize, coordinate, and supervise the gap analysis against new and revised GMP regulations, ensure the implementation of the identified measures

​• Product Quality Reviews (PQR) & Drug Annual Report management
• Ensures standard operating procedures (SOP’s) stay current and align with corporate and regulatory requirements
• Executes training/awareness related to GMP standards

Qualifications:
• University degree in a relevant scientific discipline (Pharmacy, Chemistry, Biology, Biochemistry)
• 3+ years' GMP experience in pharmaceutical/biotech or other regulated industry
• Knowledge of current Good Manufacturing Practices (cGMP) principles

Our Benefits

We encourage you to make your well-being a priority. It’s important and so are you.



  • Wuhan, Hubei, China Allegro MicroSystems Full time

    Job OverviewWe are seeking a highly motivated Electrical Systems Applications Specialist to join our team in Shenzhen, China. The successful candidate will be responsible for driving sales growth through value sales and demand creation from new markets, products, and customers.


  • Wuhan, Hubei, China Garrett - Advancing Motion Full time

    Job Description: We are seeking a highly skilled Software Systems Development Specialist to join our team at Garrett - Advancing Motion. This role will involve designing, developing, and integrating complex application functions across multiple programs. The successful candidate will have a strong understanding of software development principles, tools, and...


  • Wuhan, Hubei, China Lenovo Full time

    Job Title: Senior Windows Driver Engineer (Network)  Lenovo is seeking a highly skilled Senior Windows Driver Engineer (Network) to join our team.  Salary Range:$150,000 - $200,000 per yearAbout the RoleWe are looking for an experienced Windows Driver Engineer (Network) to design and develop high-quality network drivers for our Windows operating system....


  • Wuhan, Hubei, China Lenovo Full time

    Company OverviewWe are Lenovo, a leading technology company.Job SummaryWe are seeking an experienced Senior Product Data Management Specialist to join our team in China. This role will be responsible for managing product data and E2E process management.About the RoleManage product data and E2E process management for electronics manufacturingSet up product...


  • Wuhan, Hubei, China Roche Full time

    Job DescriptionWe are seeking an experienced Senior Account Manager to join our team in Diagnostics Sales. In this role, you will be responsible for managing and monitoring the sales performance of assigned accounts, achieving sales targets set by your line manager, and implementing Key Account Management systems.The ideal candidate will have a strong...


  • Wuhan, Hubei, China Lenovo Full time

    About the RoleWe are seeking a highly skilled and experienced Senior Regulatory Compliance Specialist to join our team at Lenovo. As a key member of our regulatory compliance department, you will be responsible for ensuring that our mobile communication products meet the highest standards of safety and quality.Job DescriptionThe ideal candidate will have a...


  • Wuhan, Hubei, China Corning Full time

    Role OverviewIn this challenging and dynamic role, you will play a key part in optimizing production lines and ensuring seamless execution of customer demand.You will work closely with cross-functional teams to develop and implement efficient production schedules, leveraging your analytical skills and technical expertise to drive business results.Key...


  • Wuhan, Hubei, China Spectris Instrumentation and Systems Shanghai Ltd. (MP OpCo) Full time

    We are seeking a highly skilled and experienced Global Instrumentation Support Specialist to join our team at Spectris Instrumentation and Systems Shanghai Ltd. (MP OpCo). The successful candidate will provide exceptional technical support for our customers in Hubei, Hunan, Jiangxi, South China, and Southwest China.About the RoleThe Global Instrumentation...


  • Wuhan, Hubei, China Arrow Electronics, Inc. Full time

    Job OverviewArrow Electronics, Inc. is seeking a Senior Field Applications Engineer to drive demand creation by maximizing Arrow content on designs in the Wuhan office.About the RoleThe successful candidate will partner with the sales team across pre-and post-sales activities, providing technical support and consulting to promote demand creation. They will...


  • Wuhan, Hubei, China Lenovo Full time

    Quality Assurance for EE ComponentsLenovo seeks a Quality Assurance Specialist to manage EE component E2E quality from product NPI phase to EOL. This role involves deeply engaging with the EE R&D team and sourcing team to assess suppliers and ensure successful parts production.Manage EE component E2E quality from product NPI phase to EOL.Work with EE...


  • Wuhan, Hubei, China ASML Full time

    About the RoleThe Field Service Engineer 2 plays a crucial part in ensuring seamless operations of ASML systems at customer sites, offering expert technical assistance and support.This role requires the engineer to possess a BSc degree in a relevant technical field or equivalent experience. Experience in using computer applications, including data analysis...


  • Wuhan, China Corning Full time

    : Schedule production lines with optimizing manufacturing operations and lowest cost to fulfill customer demand in daily bucket in 2-week horizon. Collaborate with Division Supply Chain, production, QA, Engineering…etc. to optimize production line scheduling. Co-work with commercial and logistics on recycle packing material availability to support...


  • Wuhan, Hubei, China Cummins Inc. Full time

    About the RoleCummins Inc. is a global power leader that designs, manufactures, distributes and services diesel and natural gas engines and related technologies.The estimated salary for this position is $80,000 - $120,000 per year.Job DescriptionWe are seeking an entry-level/early career professional to join our team as a Technical Product Specialist - Power...


  • Wuhan, Hubei, China Onto Innovation Full time

    Onto Innovation is a leading provider of process control solutions for the semiconductor industry. We are seeking a highly skilled Field Service Specialist to join our team.Job Summary & ResponsibilitiesResponsibilitiesProvide on-site technical support and installation services for our customers.Diagnose and troubleshoot complex equipment and systems.Conduct...


  • Wuhan, Hubei, China Alfa Laval Full time

    About the RoleAt Alfa Laval, we're committed to accelerating success for our customers, people, and planet. As a Field Service Specialist, you'll play a crucial part in this mission.Your Key ResponsibilitiesExecute maintenance and minor repairs on standard products at customer sites.Investigate and resolve technical problems on standard products at customer...

  • HR Generalist

    1 month ago


    Wuhan, Hubei, China Hireio, Inc. Full time

    We are seeking a highly skilled HR professional to join our team at Hireio, Inc. as an HR Generalist - Talent Development Specialist.Company OverviewHireio, Inc. is a leading recruitment agency that specializes in connecting talented individuals with top companies. Our mission is to provide exceptional service and support to both our clients and...


  • Wuhan, Hubei, China Ikea Full time

    About This Opportunity We are seeking a highly skilled Senior Finance Administrator to join our team at IKEA. Responsibilities The successful candidate will be responsible for managing cash and monetary transactions, preparing daily reports, and assisting accountants with reconciliations and financial data management. You will also be responsible for...


  • Wuhan, Hubei, China CNES Beijing Bokai Technology Co., Ltd. Full time

    Company Overview">CNES Beijing Bokai Technology Co., Ltd. is a leading technology company dedicated to providing innovative solutions in the field of infrastructure services.Salary">We offer a competitive salary of $80,000 - $120,000 per year, depending on experience.Job Description">As a Server Infrastructure Specialist, you will be responsible for...


  • Wuhan, Hubei, China CN20 Alcon (China) Ophthalmic Product Co. Ltd Company Full time

    Job Title: Phaco Development SpecialistAt Alcon, we are driven by the meaningful work we do to help people see brilliantly. We innovate boldly, champion progress, and act with speed as the global leader in eye care. Here, you'll be recognized for your commitment and contributions and see your career like never before. Together, we go above and beyond to make...


  • Wuhan, Hubei, China ASML Full time

    Company Overview:ASML is a leading provider of lithography systems for the semiconductor industry.Salary: ¥ 450,000 - ¥ 600,000 per year.Job Description:We are seeking an experienced Senior Product Development Engineer to join our team in Shenzhen. As a key member of our PEG group, you will be responsible for developing and optimizing semiconductor...