Your Role
● 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.
Your Profile
● 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.