Sterility Assurance Lead: Aseptic Excellence & Compliance

WUXI XDC SINGAPORE PRIVATE LIMITED; Singapore; Sur place; SGD 180 000 - 300 000; Plein temps

Résumé du poste

WUXI XDC SINGAPORE PRIVATE LIMITED is seeking a senior professional to lead the site sterility assurance program for biologics and sterile drug products. You will oversee aseptic processing, environmental monitoring, and regulatory readiness across manufacturing, quality, and validation teams.

The role requires strong expertise in GMP, EU Annex 1, and FDA aseptic guidance, with experience in contamination investigations and CAPA.

Qualifications

• Bachelor, master or PhD in related life sciences field.
• Experience supporting GMP/compliance in biologics manufacturing.

Responsabilités

• Lead site sterility assurance program and ensure GMP compliance.
• Oversee aseptic processing, media fills, and process qualification.
• Review environmental monitoring, cleanroom qualification, and microbial trends.
• Investigate contamination events and drive CAPA.
• Collaborate with MSAT, Validation, Engineering, and Quality teams.
• Support regulatory inspections and customer audits.

Connaissances

Biologics experience

Aseptic manufacturing

Environmental monitoring

Regulatory inspections support

Sterile injectables

Formation

Bachelor's degree in Microbiology

Master's degree in Microbiology

PhD in Pharmaceutical Sciences or related

Description du poste

WUXI XDC SINGAPORE PRIVATE LIMITED is seeking a senior professional to lead the site sterility assurance program for biologics and sterile drug products. You will oversee aseptic processing, environmental monitoring, and regulatory readiness across manufacturing, quality, and validation teams.

The role requires strong expertise in GMP, EU Annex 1, and FDA aseptic guidance, with experience in contamination investigations and CAPA.