Regulatory Coordinator will support the Director, Regulatory Affairs and other Senior Directors in International Markets to organize and perform required tasks for regulatory affairs in order to maintain compliance with current regulations and in-house standards.
Masters in Pharmacy/ Life Sciences. Head of Quality API Vertical, responsible for defining and executing the quality strategy across QA, QC, functions to ensure alignment with commercial and manufacturing goals, regulatory compliance, and continuous improvement in API vertical operations.
You will be responsible for preparation, review, and approval of Cleaning Master Validation Plan, Cleaning Validation and Verification Protocols and Reports, Acceptance Criteria documents, Cleaning Validation matrix, and Periodic Monitoring Schedule
To support for commercial troubleshooting/remediation/Market complaints for Non-Oral manufacturing sites.
To support for timely investigation/execution and to resume commercial manufacturing and to meet market/ sales requirement.
Master or PhD of pharmaceutical. Perform statistical analyses of data from the laboratories using R and possibly other languages SAS or standard statistical software used in Sanofi, JMP, SIMCA, internal tools. Sanofi
Dissolution apparatus, GC, IR and AAS and Documentation related to QMS. To review respective GMP Documents of QC department such as analytical / worksheet of In Process and Finished Product.