Batch Record Reviewer Group Lead

Amneal

6d•Onsite

About The Position

The Batch Record Reviewer Group Lead is responsible for leading and overseeing batch record review activities across manufacturing, packaging, and related operations in a pharmaceutical manufacturing environment. This role ensures timely, accurate, and compliant review of GMP documentation in accordance with regulatory requirements, internal procedures, and quality standards.

Requirements

High School or GED - Required
2 years or more in Manufacturing or Packaging
Strong knowledge of cGMP regulations and pharmaceutical documentation practices
Excellent attention to detail and ability to identify documentation errors and trends
Effective leadership, coaching, and communication skills
Ability to manage multiple priorities and meet timelines in a fast‑paced environment
Proficiency with ERP/MES systems (e.g., JDE or equivalent) and electronic documentation systems
Strong organizational and problem‑solving skills
Ability to work cross‑functionally and communicate clearly at all levels of the organization

Responsibilities

Lead and perform detailed review of executed batch records (manufacturing, packaging, labeling, and R&D as applicable) for accuracy, completeness, and GMP compliance.
Review work output for quality, consistency, and adherence to procedures.
Serve as an escalation point for complex documentation issues or cross‑departmental concerns.
Review and update manufacturing execution systems and/or ERP systems (e.g., JDE or equivalent) to ensure accurate batch status and documentation records.
Coordinate issuance, control, and reconciliation of batch records, logbooks, labels, and controlled documents.
Communicate documentation findings, trends, and improvement opportunities to supervisors and management.
Collaborate with Manufacturing, Packaging, Quality Assurance, Production Planning, and Supply Chain to support work order execution and documentation readiness.
Identify recurring documentation errors and support corrective and preventive actions (CAPAs).
Participate in process improvement initiatives to enhance documentation accuracy, efficiency, and compliance.
Perform other duties as assigned to support quality and operational excellence.