GxP QA Specialist - Foundation & Compliance

Roche; Welwyn; On-site; GBP 55,000 - 75,000; Full time

Benefits offered by this job

Flexible working options

18 weeks maternity leave

10 weeks gender independent partner/ p

Job summary

Roche UK seeks a Quality Assurance professional to manage key QMS processes and support Qualified Persons. You will translate global GxP requirements into Roche policies, drive compliance, and work within a dynamic, cross-functional team to safeguard Licence to Operate.

Ideal candidates hold a science degree and have hands-on experience with inspections, CAPA, and batch release processes in a GMP/GxP environment.

Qualifications

• Experience in a GxP Quality Assurance role providing quality and compliance expertise in support of unplanned and planned events, CAPA management, document management and Quality Risk Management.
• Commercial and/or Clinical Batch Record review for product release.
• Health Authority inspections experience.

Responsibilities

• Operational management of key Pharmaceutical Quality Management System (QMS) processes and supporting the Qualified Persons in fulfilling their obligations.
• Translate external and global GxP quality requirements into Roche policies and procedures.
• Be adaptable to change and entrepreneurial in order to identify opportunities while ensuring compliance and maintaining Roche UK's Licence to Operate.
• Collaborate within an empowered, self-managed, multi-skilled team to deliver foundational and squad-prioritised work.
• Be authentic, self-accountable, creative problem solver and cultivate collaborative relationships across the organisation.

Skills

GxP QA experience

Batch record review

Health Authority inspections

Education

Bachelor Degree in Science

Job description

Roche UK seeks a Quality Assurance professional to manage key QMS processes and support Qualified Persons. You will translate global GxP requirements into Roche policies, drive compliance, and work within a dynamic, cross-functional team to safeguard Licence to Operate.

Ideal candidates hold a science degree and have hands-on experience with inspections, CAPA, and batch release processes in a GMP/GxP environment.