Senior QA Compliance - Materials Management

Bristol Myers Squibb; Fingal; On-site; EUR 70,000 - 90,000; Full time

Benefits offered by this job

Competitive salary

Pension

Health insurance

Annual leave 27 days

On-site gym

Life assurance

Job summary

Bristol Myers Squibb is seeking a Snr Specialist, QA Compliance Materials Management to support material qualification and release for Cruiserath Biologics. The role reports to the Senior Manager, QA Compliance and covers qualification documentation, QA disposition, and procedures across the biologics portfolio.

The successful candidate will contribute to change controls, deviations, investigations, supplier activities, CAPAs, and continuous improvement initiatives while working in a

Qualifications

• BSc in Science or related discipline with minimum 3 years’ QA or related experience in a Biologics or Pharmaceutical environment.
• Understanding of cGMP requirements for manufacturing and/or systems and compliance.
• Knowledge of material qualification & SAP would be a distinct advantage.

Responsibilities

• Prepare, review and approve Material Qualification Documentation.
• QA disposition of raw materials, level 1 & level 2 consumables.
• Author and approve QA-related procedures.
• QA review, assessment and approval activities for Biologics Manufacture (Change controls, Deviations/Investigations, Supplier Investigations, CAPAs, SCN, TSE Certificates).
• Support establishment of Operational Excellence initiatives (5S / Std Work / LSW / Kaizen).
• Be a core team member of the QA Compliance Materials Management team.

Skills

QA compliance

cGMP knowledge

Communication skills

Time management

Team collaboration

Education

BSc in Science or related

Tools

SAP

Job description

Bristol Myers Squibb is seeking a Snr Specialist, QA Compliance Materials Management to support material qualification and release for Cruiserath Biologics. The role reports to the Senior Manager, QA Compliance and covers qualification documentation, QA disposition, and procedures across the biologics portfolio.

The successful candidate will contribute to change controls, deviations, investigations, supplier activities, CAPAs, and continuous improvement initiatives while working in a