Senior Specialist, Operation, Qa For Manufacturing
AstraZeneca
Suzhou, China
Shop floor quality oversight
Gmp documentation review and approval
Aseptic processing and contamination control
Perform shop floor quality oversight for cell therapy products to ensure manufacturing compliance with GMP requirements and approved procedures
Job Summary
Perform shop floor quality oversight for cell therapy products to ensure manufacturing compliance with GMP requirements and approved procedures.
Lead and influence Quality professionals, participate in project teams, and support internal audits and CAPA implementation to ensure GMP and regulatory compliance.
Proactively participate in company initiatives for continuous improvement, provide guidance, and monitor Key Performance Indicators (KPIs) to maintain product quality and patient safety.
Matching Summary
Perform shop floor quality oversight for cell therapy products to ensure manufacturing compliance with GMP requirements and approved procedures.
Skills & Requirements
Must-have
Shop floor quality oversight
GMP documentation review and approval
Aseptic processing and contamination control
Quality Risk Assessments
CAPA development and implementation
Continuous improvement initiatives
Nice-to-have
Ownership and urgency
Collaboration and continuous improvement mindset
Inspection-ready environments
Patient safety focus
Key Requirements
5+ years in GMP cell therapy, biologics, or sterile manufacturing
Bachelor’s degree in pharmacy, Life Sciences, Biotechnology or related field
Familiarity with CFDA GMP, EU GMP (Annex 1), PIC/S, US FDA guidance
Experience with autologous or allogeneic workflows preferred
PMP, Lean Six Sigma, or GAMP qualifications preferred