QA Shop Floor Specialist - Real-Time Quality & Compliance

Boehringer Ingelheim; Knaphill; Sur place; GBP 45 000 - 65 000; Plein temps

Résumé du poste

Boehringer Ingelheim UK is seeking a QA Shop Floor Specialist to provide real-time QA support on the production floor, ensuring EU GMP compliance, data integrity, and adherence to internal standards. This fully site-based role at Pirbright requires strong judgment, prioritization, and a proactive approach to resolving quality events that could affect products and processes.

You will coach and collaborate with operations to drive continuous improvement, support investigations, review batch

Qualifications

• Bachelor's degree in a scientific or technical discipline.
• Experience in quality within life sciences or related regulated environment.

Responsabilités

• Provide real-time QA support on the shop floor, ensuring GMP and data integrity compliance.
• Review and approve batch records and manufacturing documentation.
• Lead investigations (deviations, discrepancies, OOX, complaints) and QA assessments.
• Perform risk-based evaluations and manage materials handling, CAPAs, and change controls.
• Support validation, qualification, and maintenance across manufacturing systems.

Connaissances

EU GMP knowledge

Quality Systems

Batch record review

Deviations & CAPA

Validation & qualification

Electronic QA tools

Regulatory compliance

Root cause analysis

Decision making

Stakeholder communication

Coaching operators

Formation

Bachelor's degree in science/technical

Outils

TrackWise

e-DMS

Description du poste

Boehringer Ingelheim UK is seeking a QA Shop Floor Specialist to provide real-time QA support on the production floor, ensuring EU GMP compliance, data integrity, and adherence to internal standards. This fully site-based role at Pirbright requires strong judgment, prioritization, and a proactive approach to resolving quality events that could affect products and processes.

You will coach and collaborate with operations to drive continuous improvement, support investigations, review batch