Back to jobsLead and manage the batch record review group ensuring timely, accurate and compliant disposition of finished product batches.
Coordinates cross-functional activities among Production, QC Chemistry, QC Microbiology, QA Investigations, Supply Chain and sometimes Regulatory Affairs.
Maintains batch disposition records and reports metrics regarding release cycle times, quality trends, and leading / lagging key performance indicators (KPIs) for the use of site-level Executive Leadership and above site-level Executive Leadership.
Performs QA Functional Review of deviations (Exceptions) and OOS investigations ensuring the investigations meet CGMP standards and are scientifically defensible.
Reviews and approves batch release-related data in support of Annual Product Quality Reviews (APQRs).
Supports regulatory inspections and customer-based and internal audits as the primary expert on the batch release system.
Provides leadership, coaching and mentoring to QA personnel involved in the batch release review and release activities.
Stays current with industry expectations and regulatory requirements for CGMPs.
Performs other duties as assigned by management