Real-Time QA Specialist — GMP Manufacturing Excellence

Boehringer Ingelheim; Pirbright; On-site; GBP 40,000 - 55,000; Full time

Job summary

Boehringer Ingelheim in Pirbright, UK, seeks a QA Shop Floor Specialist to provide real-time QA support on the manufacturing floor, ensuring compliance with EU GMP and internal Boehringer standards. The role requires independent judgment, prioritisation of tasks, and proactive handling of quality events to protect products and processes.

This site-based, fixed-term position runs until 31 December 2027 and involves reviewing batch records, supporting investigations, CAPAs and change controls, and

Qualifications

• Bachelor's degree in a scientific or technical discipline.
• Relevant Quality experience within a life sciences or related regulated industry.
• Strong knowledge of EU GMP, QA, and QA systems.
• Experience with batch records review and documentation approval.

Responsibilities

• Provide real-time QA support on the shop floor, ensuring GMP compliance and data integrity.
• Review and approve batch records and manufacturing documentation.
• Support and lead investigations, including deviations and CAPA.
• Perform risk-based evaluations and ensure compliant handling of materials.
• Review and approve CAPAs and change controls, ensuring effectiveness.
• Support validation, qualification, and maintenance activities.
• Monitor QMS activities and ensure timely closure of issues.
• Identify trends and drive continuous improvement with operations.
• Ensure audit and inspection readiness and participate in internal/regulatory audits.
• Promote quality risk management and a strong quality culture.

Skills

EU GMP

Quality Assurance

Quality Systems

Batch record review

Deviations investigations

CAPA & change control

Problem solving

Regulated manufacturing

Education

Bachelor's degree in a scientific or technical discipline

Tools

TrackWise

e-DMS

Job description

Boehringer Ingelheim in Pirbright, UK, seeks a QA Shop Floor Specialist to provide real-time QA support on the manufacturing floor, ensuring compliance with EU GMP and internal Boehringer standards. The role requires independent judgment, prioritisation of tasks, and proactive handling of quality events to protect products and processes.

This site-based, fixed-term position runs until 31 December 2027 and involves reviewing batch records, supporting investigations, CAPAs and change controls, and