Conduct literature survey and compile the scientific findings for allocated projects. Plan and perform the Pre-formulation studies, and innovator product characterization.
Management and performing periodic observation of retain sample & identified the deviation through periodic observation. Review of Temperature, RH data in retained samples area.
Should maintain R Vs C Vs A metrics with actuals and Gap and shall populate the data with all CFT in weekly meet.
Should be able to handle procurement plan through SAP with good knowledge to carry out MRP process in SAP, knowledge of Kinax is will be additional advantage.
The Regulatory Affairs Manager II is fully proficient in applying established standards and performs regulatory affairs management for moderately to highly complex international market submissions in all regions with minimal coaching. They are expected to facilitate strategic input, provide proactive contribution to submission planning, identify areas for continuous improvement, and lead cross-functional activities. They participate in the continuous improvement of processes and tools, systems.
Method validation, verification and transfer to Quality control lab for OSD and PFOS formulations. Development, optimization and validation of analytical methods to support OSD formulation ANDA.
M.Sc/ Mpharm/ PhD; Deep understanding of various analytical tools and supporting software like Empower, OpenLab CDS, LabSolutions. And Chromeleon; This role focuses on analytical method development for route scouting, process development, and the scale-up of various crop protection products. The ideal candidate will have a skill set to operate and develop methods on GC-MS, LC-MS, and UPLC/UHPLC.