Senior Specialist, Validation, Qa

Zse68

Facility and equipment qualification
Aseptic process simulation coordination
Validation documentation and compliance
The role involves coordinating qualification of cleanrooms, HVAC, process gases, and critical equipment to ensure compliance with GMP standards

Job Summary

  • The role involves coordinating qualification of cleanrooms, HVAC, process gases, and critical equipment to ensure compliance with GMP standards.
  • The Senior Specialist will lead validation documentation, risk management, and prepare the site for audits and inspections as the validation SME.
  • AstraZeneca is committed to building an inclusive and diverse team and welcomes applications from all qualified candidates.

Matching Summary

The role involves coordinating qualification of cleanrooms, HVAC, process gases, and critical equipment to ensure compliance with GMP standards.

Skills & Requirements

Must-have

  • Facility and equipment qualification
  • Aseptic process simulation coordination
  • Validation documentation and compliance
  • Risk management and mitigation
  • Audit and inspection readiness
  • GMP sterile manufacturing experience

Nice-to-have

  • Continuous improvement mindset
  • Collaboration and ownership
  • Experience with autologous or allogeneic workflows
  • Comfortable in high-stakes environments
  • Willingness to travel and work off-hours

Key Requirements

  • Bachelor’s degree in pharmacy, Life Sciences, or related field
  • 5+ years GMP cell therapy or biologics experience
  • 2+ years validation project or team management
  • Familiarity with CFDA GMP, EU GMP Annex 1, PIC/S, US FDA guidance
  • Experience with qualification instruments
  • Work authorization and employment eligibility

Work Rights

Not specified

Tailored Resume

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