Senior QA Materials Compliance Specialist – Biologics

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

Benefits offered by this job

Annual bonus

Pension contribution

Family health insurance

27 days annual leave

On-site gym

Life assurance

Job summary

Bristol Myers Squibb is seeking a Snr Specialist, QA Compliance Materials Management at the Cruiserath Biologics site. You will support material qualification and release activities for biologics and clinical pipelines, reporting to the Senior Manager, QA Compliance.

The role involves QA documentation, change controls, deviations, investigations and supplier-related activities. Ideal candidates hold a BSc in Science or related discipline with at least 3 years' QA experience in pharma/biologics,

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
• Able to work independently as well as part of a matrix team to meet accelerated timelines
• Excellent communication and presentation skills

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, including change controls
• Deviations/Investigations, Supplier Investigations, CAPAs
• Supplier Change Notifications and TSE Certificates
• Support establishment of Operational Excellence initiatives

Skills

QA Compliance

cGMP Knowledge

Team Collaboration

Excellent Communication

Education

BSc in Science or related discipline

Tools

SAP

Job description

Bristol Myers Squibb is seeking a Snr Specialist, QA Compliance Materials Management at the Cruiserath Biologics site. You will support material qualification and release activities for biologics and clinical pipelines, reporting to the Senior Manager, QA Compliance.

The role involves QA documentation, change controls, deviations, investigations and supplier-related activities. Ideal candidates hold a BSc in Science or related discipline with at least 3 years' QA experience in pharma/biologics,