Vacancy has expired
Show me jobs like this one| Job Ref: | 50376BR |
| Sector: | Pharmaceutical and Medical Device |
| Job Type: | Full Time |
| State: | California (CA) |
| City: | Los Angeles |
| Post Code: | Dec 09, 2011 |
| Job Description: |
This position has responsibility for ensuring the activities associated with on floor review and finished product release are properly incorporated into the new MES (EBM) project for LAMP. The incumbent will direct the development, implementation, deployment and ongoing continuous improvement of Pharma Release for the LAMP Building 8 facility consistent with the MES project objectives and LA Plant strategic plan. The Pharma Release Specialist will ensure compliance to all product and material release requirements in accordance with the MES project objectives and the quality plan. The position is responsible for supporting development of electronic batch record software, ensuring the requirements of Product Release are incorporated into the electronic batch record software, and ensuring compliance to all applicable state, federal and international regulations. * Serves as technical expert on Pharma Product Release and ensures the required activities of pharma product release are incorporated into the electronic batch record software. * Implements the quality systems procedures in the product release and batch record review activities associated with the product release portion of the electronic batch record. * Understands and assures conformance to local, federal and international regulations and will interface with regulators during Building 8 related inspections. * Participates in developing and managing requirements of suppliers to analyze compliance and assess risk. * Interacts frequently with software development engineers, software development contractors, Quality System and LA Plant Product Release SMEs, functional peers and senior group managers and directors. * Manages interactions relative to LAMP Building 8 Pharma Product Release with regulators and customers to represent the company products and processes. * Identifies and manages continuous improvement projects with the objective of achieving quality, reliability and cost improvements. * Assists with development of LAMP Quality budget and ensures adherence to the Pharma Product Release portion of the Quality budget. * Ensures Quality System and Product Release requirements are soundly embedded in the MES project and associated software and processes. Requirements * Thorough knowledge of applicable procedures, specifications, regulations and standards. |
| Post Date: | 12/10/2011 |
