Senior Specialist, Validation, Qa

AstraZeneca

Suzhou, China
**
Facility & utilities qualification
Equipment qualification iq/oq/pq
Aseptic process stimulation
** AstraZeneca is seeking a Senior Specialist in Validation within their Suzhou, China facility. The role involves overseeing facility and equipment qualification, ensuring compliance with GMP standards, and leading validation projects in a sterile manufacturing environment. **

Job Summary

  • Coordinate qualification of cleanrooms, HVAC, process gases, and PW/PS systems, ensuring environmental monitoring programs are defined and validated.
  • Plan and witness IQ/OQ/PQ for critical assets, including communication with equipment suppliers or third-party validation service providers.
  • As the validation SME, prepare the site for internal audits and health authority/customer inspections regarding validation, and drive closure of findings.

Matching Summary

Match Score: 75

** AstraZeneca is seeking a Senior Specialist in Validation within their Suzhou, China facility. The role involves overseeing facility and equipment qualification, ensuring compliance with GMP standards, and leading validation projects in a sterile manufacturing environment. **

Skills & Requirements

Must-have

  • Facility & Utilities Qualification
  • Equipment Qualification IQ/OQ/PQ
  • Aseptic process stimulation
  • Validation documentation and compliance
  • Risk management for sterility assurance
  • Audit and inspection readiness

Nice-to-have

  • Continuous improvement mindset
  • Collaboration and ownership
  • Comfortable in inspection-ready environments

Key Requirements

  • Bachelor’s degree in pharmacy, Life Sciences, Biotechnology or related field
  • 5+ years in GMP cell therapy, biologics, or sterile manufacturing
  • 2+ years of experience as a validation project manager or team manager
  • Familiarity with CFDA GMP, EU GMP (including Annex 1), PIC/S, US FDA guidance, ICH Q7/Q8/Q9/Q10, GAMP 5, ISO 14644, ISPE Baseline Guides, and data integrity (ALCOA+)

Work Rights

Not specified

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