Senior QC Projects & Trending Specialist - Impact & Growth

Bristol Myers Squibb UK & Ireland; Leinster; Vor Ort; EUR 65.000 - 90.000; Vollzeit

Benefits dieser Stelle

Annual bonus

Pension contribution

Family health insurance

27 days annual leave

On-site gym

Life assurance

Zusammenfassung

Bristol Myers Squibb UK & Ireland is seeking a Senior Specialist, QC Projects & Trending to drive analytical trending, QC project management and regulatory compliance at our Ireland site. You will coordinate APQRs, monitor method performance, and lead continuous improvement initiatives with cross-functional teams.

The role requires a B.Sc. in Biochemistry or related, 2+ years GMP lab experience, and strong communication and collaboration skills to influence decisions across QC functions and with

Qualifikationen

• Minimum B.Sc. in Biochemistry, Pharmaceutical Science, or a closely related discipline.
• At least 2 years' experience in a GMP laboratory environment, ideally within a biologics setting.
• Demonstrate excellent written and verbal communication skills and experience of working with teams and influencing decisions.
• A strong knowledge of laboratory operation, in particular training and testing requirements from receipt to CoA is required.
• Proven ability to work flexibly within a team environment and adapt to changing business needs.

Aufgaben

• Define, schedule, coordinate, and drive activities required for completion of all Annual Product Quality Reviews (APQRs) and annual trend reports, ensuring timely delivery in line with due dates.
• Contribute to the Cruiserath Method Performance Monitoring Programme, incorporating reference standard monitoring and invalid rate tracking.
• Conduct trend assessments in collaboration with SMEs, ensuring outcomes are clearly documented and actioned.
• Manage the addition of new products to the trending programme following successful transfer to the Cruiserath QC teams.
• Approve SOPs, trend data, non-conformance reports, and related documentation in accordance with GMP requirements.

Kenntnisse

GMP knowledge

Analytical trending

QC systems

Stakeholder management

Communication

Ausbildung

B.Sc. in Biochemistry or related

Tools

Smart QC

Jobbeschreibung

Bristol Myers Squibb UK & Ireland is seeking a Senior Specialist, QC Projects & Trending to drive analytical trending, QC project management and regulatory compliance at our Ireland site. You will coordinate APQRs, monitor method performance, and lead continuous improvement initiatives with cross-functional teams.

The role requires a B.Sc. in Biochemistry or related, 2+ years GMP lab experience, and strong communication and collaboration skills to influence decisions across QC functions and with