Senior QA Materials Compliance Lead

Bristol Myers Squibb

Ireland

On-site

EUR 60,000 - 90,000

Full time

8 days ago

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Benefits offered by this job

Annual bonus

Pension contribution

Family health insurance

27 days annual leave

On-site gym access

Life assurance

Job summary

Bristol Myers Squibb (BMS) Cruiserath Biologics seeks a Senior Specialist, QA Compliance Materials Management to support material qualification and release for its biologics portfolio at the Cruiserath facility. The role reports to the Senior Manager, QA Compliance and requires a strong QA background in biologics/pharmaceuticals.

You will be part of a core QA Compliance Materials Management team, driving improvements and ensuring regulatory and quality standards are met across supplier changes,

Qualifications

BSc in Science or related discipline with min 3 years QA experience.
Clear understanding of cGMP requirements for manufacturing/systems.
Knowledge of material qualification and SAP is a plus.
Ability to work independently and in a matrix team to meet timelines.
Excellent communication and presentation skills are essential.

Responsibilities

Prepare, review and approve Material Qualification Documentation.
QA disposition of raw materials and consumables.
Authoring, review and approval of QA-related procedures.
QA review, assessment and approval for Biologics Manufacture, incl. change controls.
Handle Deviations/Investigations and Supplier Investigations.

Skills

BSc in Science

QA Experience

cGMP knowledge

SAP familiarity

Teamwork

Communication

Education

BSc in Science or related discipline

Tools

SAP

Job description

You will be part of a core QA Compliance Materials Management team, driving improvements and ensuring regulatory and quality standards are met across supplier changes,

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