Responsible for timely and effective GMP review and production close-out of batch record documentation in order to maintain a continuous flow of right the first time batch records to QA.
MES/SAP/LIMS Super User to include floor support and training.
SPOC for Batch Record Process includes creating reports; production terminating and approving records; issue resolution.
Reviews all batch documentation for accuracy and completeness according to cGMP's to ensure timely release.
Ensures deviations are initiated for any batch record review related events Find/communicate deviations to QA compliance group/help with investigation
Adheres to internal/external guidelines, specifications and regulatory requirements while reviewing batch documentation.
Ensures all GMP's, Work Procedures and SOP's are followed.
Positively interacts with internal associates to quickly and effectively resolve batch record documentation related issues.
Addresses deficiencies and ensures completion of all follow-up actions, specifically those that target process fixes to maintain consistent resolutions to all batch review issues according to GMP standards and *** objectives.
Within MES, is responsible for TECO all Manufacturing orders.
Track monthly Batch Record related KPI's and develop slides for the Site Monthly Dashboard.
Provide periodic updates at Manufacturing Team meetings to review current batch record errors to improve performance.
Archive correction log sheets in Doc Control (activity will stop with MES)
Train new manufacturing associates on batch record review
Maintains strong collaborative relations with the Quality Assuance Group
Batch Record Right First Time (cockpit KPI)
Batch Right First Time Rate (cockpit KPI)
Through Put Time (22 days)
This professional must be proactive, responsive, and able to work independently with all levels of the organization. Must possess full fluency in MS Office (Word, Outlook, PowerPoint, MES, database management) and be an excellent communicator. Must be service-minded, flexible, and possess strong interpersonal skills. Capability to handle multiple conflicting tasks in a fast-paced environment is a must. Very high attention to detail is critical, including strong writing skills. Skilled in Good Documentation Practices.
Source: Job Diva – Job Listing