Senior QA Compliance Specialist, Materials Management

Bristol Myers Squibb UK & Ireland; Ireland; Sur place; EUR 70 000 - 90 000; Plein temps

Avantages offerts par ce poste

Annual bonus

Pension

Family health insurance

27 days annual leave

On-site gym

Life assurance

Résumé du poste

Bristol Myers Squibb UK & Ireland is seeking a Senior Specialist, QA Compliance Materials Management, to support material qualification and release for Cruiserath biologics manufacturing.

The role reports to the Senior Manager, QA Compliance, and requires independent work within a matrix team to meet accelerated timelines while driving quality and compliance across the portfolio and clinical pipeline.

Qualifications

• BSc in Science or related discipline with a minimum of 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.

Responsabilités

• 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, SCN, TSE Certificates, and other 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).

Connaissances

cGMP knowledge

Formation

BSc in Science or related discipline

Outils

SAP

Description du poste

Bristol Myers Squibb UK & Ireland is seeking a Senior Specialist, QA Compliance Materials Management, to support material qualification and release for Cruiserath biologics manufacturing.

The role reports to the Senior Manager, QA Compliance, and requires independent work within a matrix team to meet accelerated timelines while driving quality and compliance across the portfolio and clinical pipeline.