Senior QA Materials & Compliance Specialist

Bristol-Myers Squibb Co; Cruiserath; Sur place; EUR 60 000 - 80 000; Plein temps

Avantages offerts par ce poste

Annual bonus

Pension contribution

Family health insurance

27 days annual leave

On-site gym access

Life assurance

Résumé du poste

Bristol Myers Squibb (BMS) Cruiserath Biologics is seeking a Senior Specialist, QA Compliance Materials Management to support material qualification and release for its biologics portfolio. The role reports to the Senior Manager, QA Compliance and requires strong cGMP knowledge and SAP experience.

The successful candidate will work in a fast-paced QA environment, collaborate across matrix teams, and contribute to continuous improvement initiatives.

Qualifications

• BSc in Science or related discipline required, plus 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.
• Excellent communication and presentation skills are essential.
• Strong time management and organizational skills with the ability to multi-task.

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, including change controls, deviations/investigations, supplier investigations, CAPAs, supplier change notifications, TSE certificates and related documentation.
• Be a core team member of the QA Compliance Materials Management team and participate in other support activities as required.
• Support Operational Excellence initiatives such as 5S, Std Work, LSW, Kaizen, and Problem Solving.

Connaissances

QA Compliance

cGMP

SAP knowledge

Communication skills

Time management

Teamwork

Formation

BSc in Science or related discipline

Outils

SAP

Description du poste

Bristol Myers Squibb (BMS) Cruiserath Biologics is seeking a Senior Specialist, QA Compliance Materials Management to support material qualification and release for its biologics portfolio. The role reports to the Senior Manager, QA Compliance and requires strong cGMP knowledge and SAP experience.

The successful candidate will work in a fast-paced QA environment, collaborate across matrix teams, and contribute to continuous improvement initiatives.