Senior QA Compliance Materials Specialist

Bristol Myers Squibb UK & Ireland; Dublin; On-site; EUR 65,000 - 90,000; Full time

Job summary

Bristol Myers Squibb UK & Ireland is seeking a Snr Specialist, QA Compliance Materials Management at their Cruiserath facility. The role focuses on material qualification, release activities, and ensuring cGMP compliance for biologics manufacturing.

The ideal candidate holds a BSc in Science and 3+ years of QA experience in biologics/pharma, with SAP knowledge as a plus. The position requires teamwork across a matrix and will drive quality across the portfolio and pipeline.

Qualifications

• Minimum 3 years’ QA or related experience in a Biologics or Pharmaceutical environment
• Clear understanding of cGMP requirements for manufacturing and/or systems and compliance
• Knowledge of material qualification & SAP would be a distinct advantage
• Must be able to work in a team and across a matrix to meet accelerated timelines

Responsibilities

• Preparation, review and approval of Material Qualification Documentation
• QA disposition of raw materials, level 1 & level 2 consumables
• Authoring, review and approval of QA‑related procedures
• QA review, assessment and approval activities for Biologics Manufacture, as applicable, for
• Change controls
• Deviations/Investigations
• Supplier Investigations
• CAPAs
• Supplier Change Notifications (SCN)
• TSE (Transmissible Spongiform Encephalopathy) Certificates
• Other associated documentation
• Be a core team member of the QA Compliance Materials Management team engaging in other support activities as required
• Support establishment of Operational Excellence initiatives e.g., 5S / Std Work / LSW / Kaizen / Problem Solving etc.

Skills

QA experience

cGMP understanding

Team collaboration

Education

BSc in Science or related discipline

Tools

SAP

Job description

Bristol Myers Squibb UK & Ireland is seeking a Snr Specialist, QA Compliance Materials Management at their Cruiserath facility. The role focuses on material qualification, release activities, and ensuring cGMP compliance for biologics manufacturing.

The ideal candidate holds a BSc in Science and 3+ years of QA experience in biologics/pharma, with SAP knowledge as a plus. The position requires teamwork across a matrix and will drive quality across the portfolio and pipeline.