Batch Record Review Supervisor

Job description

SUMMARY: Supervise the batch record review group. Responsible for oversight of the batch record review process to ensure it satisfies GMP and GDP requirements. Responsible for supporting the company with timely and accurate release of documentation to meet customers’ requirements. Responsible for supervising the batch record reviewers and ensuring they meet their responsibilities. This includes a review of line documentation related to contract packaging. Will follow-up on customer inquiries as they relate to same documentation and compliance issues. Responsible for participating in internal, external and regulatory audits at the discretion of senior management. Position is responsible for final documentation review and ultimate release for product distribution. The impact of the review process could expose the company to criticism from customers. ESSENTIAL DUTIES AND RESPONSIBILITIES: The following is a list of minimum responsibilities related to the Supervisor Batch Record Review position. Other duties may also be assigned. Responsible for assigning work to the batch record reviewers. Responsible for prioritizing workloads of the batch record reviewers. Responsible for ensuring a...