- As a validation and quality expert, you will collaborate with the China hub CP&R and QUM teams to support all CP&R and QUM-related tasks for each roll-in legal entity in China.
- You will oversee local CSV execution in alignment with approved MVP and LVP standards, demonstrating a proactive approach in working across various workstreams to drive the successful completion of CSV activities.
- Your responsibilities include ensuring that all validation deliverables are prepared and available for NMPA inspections and supporting regulated legal entities in maintaining compliance with GMP/GSP requirements.
- You will work closely with both global and local CIT teams to identify GXP-related systems and infrastructure, conduct IT vendor qualifications, organize risk assessments, and execute system qualifications to ensure that IT infrastructure and applications comply with both local and global validation strategies.
- Additionally, you will manage and coordinate data migration validation processes, safeguarding data integrity throughout migrations.
- You will also prepare GXP-related documentation for FIT 4 China and be responsible for organizing and coordinating computer system validation training programs, providing guidance to workstreams to ensure correct execution of validation tests.
- Critical support for GXP testing is also required as part of this role
- Bachelor degree in life science, medical device or information technology related area.
- Experience in Computer System Validation (CSV) is highly preferred.
- Have basic GMP knowledge in Medical device or Life science or Pharma industry.
- Rich experience in medical device quality systems, with familiarity of regulations and standards such as ISO 13485 ,GMP and NMPA.
- Fluently in oral and writing English.
- You have a strong ability to work in international and cross-functional teams, paired with a consulting orientation and excellent communication skills.
- Have passion to work in a complex working environment.
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ZEISS is an internationally leading technology enterprise operating in the fields of optics and optoelectronics. In the previous fiscal year, the ZEISS Group generated annual revenue totaling 10 billion euros in its four segments Semiconductor Manufacturing Technology, Industrial Quality & Research, Medical Technology and Consumer Markets (status: 30 September 2023). With around 43,000 employees, ZEISS is active globally in almost 50 countries with around 30 production sites, 60 sales and service companies and 27 research and development facilities (status: 30 September 2023). Founded in 1846 in Jena, the company is headquartered in Oberkochen, Germany. The Carl Zeiss Foundation, one of the largest foundations in Germany committed to the promotion of science, is the sole owner of the holding company, Carl Zeiss AG. Data privacy: www.zeiss.com/data-protection Imprint: http://zeiss.com/publisher This is ZEISS's official LinkedIn account. It follows the ZEISS Netiquette: www.zeiss.com/netiquette
