QA BMR Reviewer

QA BMR Reviewer / Technician

We are currently recruiting for a QA BMR Reviewer / Technician to join the Quality Assurance team of a leading pharmaceutical manufacturing company. This role is ideal for a quality-focused professional with experience in GMP-regulated environments who is passionate about ensuring compliance, documentation accuracy, and product quality.

Working within the QA department, you will play a key role in reviewing Batch Manufacturing Records (BMRs), supporting batch release activities, and maintaining quality systems in line with regulatory requirements.

Key Responsibilities: 

• Review Intermediate and Finished Product Batch Manufacturing Records (BMRs) and associated documentation for completeness, accuracy, and compliance.
• Verify Critical Process Parameters (CPPs) to ensure manufacturing processes have been executed in accordance with approved procedures.
• Raise and support the completion of quality records, including Deviations, CAPAs, Change Controls, Non-Conformances, and Document Change Requests (DCRs).
• Prepare and collate documentation to support Qualified Person (QP) batch release activities in line with regulatory requirements.
• Issue and manage Batch Manufacturing Records and logbooks using electronic document management systems.
• Maintain document control activities, including reconciliation, archiving, retrieval, and record management.
• Support QA/GMP compliance programmes and quality system initiatives.
• Manage the retention of product samples and quality documentation.
• Participate in internal and external audits, providing QA support as required.
• Deliver training and guidance on GMP procedures and quality-related activities where appropriate.
• Contribute to continuous improvement initiatives and cross-functional projects.
• Provide updates on documentation review status and collaborate effectively with Production, QC, Engineering, and other departments.

About You:

The successful candidate will have:

• A third-level qualification in a scientific discipline (BSc or equivalent preferred).
• Previous experience within a pharmaceutical or highly regulated manufacturing environment.
• A solid understanding of cGMP requirements and Good Documentation Practices (GDP).
• Knowledge of FDA and EMA regulatory expectations.
• Excellent attention to detail with a methodical and organised approach.
• Strong communication and interpersonal skills.
• The ability to prioritise workloads and meet deadlines in a fast-paced environment.
• Experience using electronic quality management or document management systems is advantageous.

For a confidential conversation about the role please apply for the role or contact Owen Clancy at oclancy@sterlingengineeringeu.com By applying to this job post you agree that Sterling Engineering may process your personal data for recruitment purpose