BMR Reviewer Specialist

Work Schedule

Standard (Mon-Fri)

Able to lift 40 lbs. without assistance, Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Office

The Role

We are seeking 3
Batch Record Reviewer – Documentation Specialists to join our Production team. This role provides critical support for batch record review, production documentation, and training activities within a GMP-regulated manufacturing environment.

You will help ensure that Batch Manufacturing Records (BMRs) and associated production documentation are accurate, complete, compliant, and reviewed in a timely manner. Working closely with Production and cross-functional teams, you will identify documentation issues and trends, provide feedback and coaching, and drive improvements in documentation quality and right-first-time performance.

As manufacturing operations run continuously, this position operates on a 24/7 rotating shift pattern, which may include days, nights, weekends, and public holidays.

In this role, you will:

• Review Batch Manufacturing Records (BMRs) for accuracy, completeness, and compliance with GMP and data integrity requirements.

• Identify and trend batch record errors, providing timely feedback and coaching to Production operators to support continuous improvement and right-first-time documentation.

• Track the progress and status of batch record reviews, ensuring records are progressed and completed within required timelines.

• Ensure timely closure of batch manufacturing steps within SAP.

• Provide day-to-day documentation support to Production teams.

• Draft and maintain manufacturing documentation, including Master Batch Records, in collaboration with Technology Transfer, Cleaning & Process Validation, and other relevant functions.

• Author and review controlled production documentation, including Standard Operating Procedures (SOPs), training forms, risk assessments, and audit trail reviews using the Electronic Document Management System (EDMS).

• Coordinate investigations relating to documentation errors and support the identification and implementation of appropriate corrective and preventive actions.

• Own and progress change controls relating to Batch Manufacturing Records and associated production documentation.

• Attend Tier 1 huddles and provide clear updates on batch record review status, priorities, risks, and outstanding actions.

• Support and deliver training to Production personnel on good documentation practices and the correct completion of manufacturing documentation.

• Apply Practical Process Improvement (PPI) principles and tools to improve batch record processes, documentation quality, and overall operational effectiveness.

• Work collaboratively with Production, Quality, Technology Transfer, Validation, and other stakeholders to ensure documentation supports safe, compliant, and efficient manufacturing operations.

To be successful in this role, you should have:

• Proven working knowledge of Good Manufacturing Practice (GMP) principles and guidelines, particularly as they relate to manufacturing activities, documentation, and data integrity.

• Some experience working within a pharmaceutical, biopharmaceutical, medical device, or similarly regulated manufacturing environment.

• Some experience reviewing or completing controlled manufacturing documentation and/or Batch Manufacturing Records.

• Strong attention to detail with the ability to identify documentation errors, discrepancies, and compliance risks.

• Good written and verbal communication skills, with the confidence to provide constructive feedback and training to Production colleagues.

• Strong organisational skills and the ability to manage multiple priorities in a fast-paced manufacturing environment.

• Strong proficiency in Microsoft Office applications and a high level of general computer literacy.

• The ability and flexibility to work a 24/7 rotating shift pattern, including day and night shifts, weekends, and public holidays .

The following would be advantageous:

• Experience with in pharmaceutical manufacturing.

• Experience with sterile filtration products or sterile manufacturing processes.

• Experience using SAP and an Electronic Document Management System (EDMS).

• Experience with deviation investigations, CAPA, change control, or other pharmaceutical quality systems.

• Experience authoring or reviewing SOPs, Master Batch Records, risk assessments, or similar GMP-controlled documentation.

• Experience…