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 Novartis 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 Assurance Group
The Novartis Group of Companies are Equal Opportunity Employers and take pride in maintaining a diverse environment. We do not discriminate in recruitment, hiring, training, promotion or any other employment practices for reasons of race, color, religion, gender, national origin, age, sexual orientation, marital or veteran status, disability, or any other legally protected status.
BS degree or equivalent pharmaceutical experience. Strong background in Good Documentation Practices (GDP) Fluent in English 1 -3 years experience in a regulated cGMP Environment. Strong aseptic manufacturing knowledge preferred
DivisionNovartis Technical Operations
Company/Legal EntityNovartis Pharmaceuticals
Job TypeFull Time