QA Analyst - Batch Release & GMP Compliance (Contract)

Boehringer Ingelheim; Knaphill; On-site; GBP 30,000 - 50,000; Full time

Benefits offered by this job

Top Employer in the UK

Job summary

Boehringer Ingelheim is seeking a Quality Assurance Analyst to ensure batch release activities meet regulatory and internal quality standards. The role focuses on reviewing batch documentation, coordinating with production, quality control, and the Qualified Person (QP) to enable timely product release.

It is a fixed-term contract until 31 December 2027, based in the UK. The ideal candidate has GMP knowledge, experience with quality systems, and familiarity with LIMS/SAP.

Qualifications

• GMP knowledge and data integrity awareness are essential.
• Experience in a regulated industry is advantageous.
• Familiarity with batch release processes is preferred.

Responsibilities

• Prepare and review batch documentation for QP certification per EU GMP Annex 16.
• Review production and formulation sheets and perform batch checks.
• Utilise LIMS and SAP for batch release activities.
• Report quality issues to stakeholders promptly and track batch records.
• Support improvement projects and document control activities.

Skills

GMP principles

Data integrity

Quality systems

Batch record review

LIMS

SAP

Attention to detail

Organisational skills

Communication skills

Problem solving

MS Office

Education

Scientific or related degree

Tools

LIMS

SAP

Job description

Boehringer Ingelheim is seeking a Quality Assurance Analyst to ensure batch release activities meet regulatory and internal quality standards. The role focuses on reviewing batch documentation, coordinating with production, quality control, and the Qualified Person (QP) to enable timely product release.

It is a fixed-term contract until 31 December 2027, based in the UK. The ideal candidate has GMP knowledge, experience with quality systems, and familiarity with LIMS/SAP.