Lot Release Protocols
Obtain data to populate Lot Release Protocols (LRPs)
Populate LRP according to procedure and submit the completed populated LRP to Batch Release management for review.
Use current master controlled lot release protocols (LRP) to populate both QO approved test and manufacturing data for submission to regulatory agencies (CBER, BRDD, and International Countries).
Ensure right first time population and accuracy of data including the highest quality laboratory data so the data is searchable under electronic LRP.
Maintain master controlled documents through the EDMS system and create new templates as required.
Publish the LRP for electronic submission to regulatory agencies. Ensure LRP submission meets cycle time requirements for product releases, and SAP confirmation for completion of activity.
Act as designee to Batch Release management for LRP reviews. Work with Regulatory Affairs as the technical expert for the preparation and review of National and International Lot Release protocols.
Batch Record Review/ Disposition
Schedule, prioritize and prepare batches for disposition as applicable for all manufacturing areas at Swiftwater and distribution of final product to market.
Assemble the batch file dossier, which are viewed during Health Authority inspections.
Prepare the Certificate of Analysis, which lists all acceptance criteria and test results related to a batch of product.
Performs cGMP review of media/reagent/product batch records and release of media/reagents/products.
Prepares and/or approves commodity verification sheets for vaccine formulation, required for manufacturing to bulk.
Performs batch record preparation and certification, required for manufacturing to execute the batch.
Follow up and work effectively with colleagues throughout the organization to ensure timely disposition of product.
Compliance and Performance
Ensure training is up to date to perform the designated cGMP activities and requirements for Health and Safety.
Record GMP data on documents (LRP and Batch Record dossiers) right first time with >95% accuracy, completeness and compliance.
Execute on time changes to master documents such as LRP aligned with revised product specifications to ensure changes are completed on time.
Complete SAP transactions in real time as activities are performed.
Meet cycle time commitments for population of LRPs per departmental agreements/commitments, support Right First Time projects.
Perform all other tasks as assigned by Manager.
Continuously reviews PQBR processes, and recommends, develops and implements efficiency and quality enhancements.
REQUIREMENTS: Specific degree, duration of experience
Key technical competencies and soft skills:
Experience in SAP, Geode+, LabWare, Trackwise, Word, Phenix.
Excellent report writing, analytical and communication/interpersonal skills, as well as strong organizational and teamwork abilities.
Good working knowledge of the cGMPs (US, Canada, Japan, Europe)
Sanofi Inc. and its U.S. affiliates are Equal Opportunity and Affirmative Action employers committed to a culturally diverse workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender, gender identity or expression; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law.
At Sanofi diversity and inclusion is foundational to how we operate and embedded in our Core Values. We recognize to truly tap into the richness diversity brings we must lead with inclusion and have a workplace where those differences can thrive and be leveraged to empower the lives of our colleagues, patients and customers. We respect and celebrate the diversity of our people, their backgrounds and experiences and provide equal opportunity for all.
Principia Biopharma Inc.