GMP-Driven QC Raw Materials Scientist (Compendial)

WuXi Biologics

Leinster

On-site

EUR 65,000 - 90,000

Full time

13 days ago
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Job summary

WuXi Biologics is seeking a QC Raw Materials and Compendial Scientist to support GMP/GLP compliant QC testing and release of raw materials in a fast-paced biopharma facility in Ireland.

Responsibilities include lab startup/maintenance, equipment qualification, method validation, documentation, audits, and staff training to ensure high-quality analytical outcomes and regulatory readiness.

Qualifications

  • University degree in science or quality discipline is required.
  • Experience in a Quality Control/GMP environment is required.
  • Experience in a large-scale biopharmaceutical facility is preferred.
  • Facility start-up project experience is desirable.
  • Experience in training personnel is desirable.

Responsibilities

  • Ensure startup and routine QC Raw Materials and Compendial laboratory operations are performed safely.
  • Support lab setup, equipment installation and qualification using Operational Excellence/Lean principles.
  • Support facility qualification and process validation activities.
  • Develop and maintain GMP/GLP-compliant quality systems in the QC lab.
  • Develop training materials for QC lab personnel.
  • Lead QC test method validation and development of routine testing strategies.
  • Author methods, protocols, qualification/validation reports, SOPs and related documents.
  • Support regulatory inspections and audits; respond to CAPAs as needed.
  • Train QC analysts and manufacturing personnel in lab methods and procedures.

Skills

Communication skills
Interpersonal skills
Presentation skills
Troubleshooting
Self-motivation

Education

Science/Quality degree

Job description

WuXi Biologics is seeking a QC Raw Materials and Compendial Scientist to support GMP/GLP compliant QC testing and release of raw materials in a fast-paced biopharma facility in Ireland.

Responsibilities include lab startup/maintenance, equipment qualification, method validation, documentation, audits, and staff training to ensure high-quality analytical outcomes and regulatory readiness.

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