About Baxter
Baxter one of the top Pharmaceutical and medical devices company, with the head quarters located in Illinois. Primary focus of treatment for the company is in the area of Hemophilia and in treating the immune and chronic medical conditions. The firm relieves the issues for millions of patients across the globe serving to the man kind from more than 85 years.
In the year 2018 Baxter was awarded for the best place to work globally. The company have the portfolio of medicines in Critical care, Nutritional, renal care, surgical and Hospital care. Apart from the pharmaceutical medicines the company also provides medical devices and infusions.
About the Job
Location : Ahmedabad
Sr. Associate in RA :
Roles :
Need to be a proactive member of the Regulatory team to ensure Baxter’s continuing compliance with regulatory authorities.
Should be effectively participate in discussions to provide strategic regulatory guidance to team members in India and other Region operations.
Required to oversee the preparation and filing of high-quality submissions to regulatory authorities.
Needed to ensure that all applications are filed in accordance with regulations and requirements.
Need to interact with all levels in the organization, and across several functions particularly Compliance, Marketing, R&D, engineering, manufacturing and QA/QC.
Timely uptake and interact with regulatory agency on regulatory submissions and follow ups of drug products.
Required and able to ensure the on-time filing of high-quality regulatory submissions, and to assist in the preparation, maintenance, and control of regulatory Dossiers.
Guidance to be Provided for regulatory staff and inter-disciplinary project teams.
For Associate Manager in R&D - FRD
Roles :
Project budget and schedule, review proposals by collaborating with other stakeholders.
Needed to abide and follow to adherence to the Baxter’s Code of conduct principles, SOP compliance about development, quality, and R&D site.
Timely understand and coordination with the Production team for successful technology transfer of new formulations.
Performing the effective technology Transfer of acquired or developed formulation products in Baxter and/or in CMOS.
Coordination with various departments like analytical, regulatory, PM, CMO, vendors, purchase, and other cross-functional teams for smooth development and project execution.
Optimization, scale-up, development of robust formulations and processes through and validation work applying QbD principles including risk assessments and DoEs.
To review and approve engineering batch & stability batch documents.
Effectively support Process validation batches, if required.
Able to handle and review the technical documents e.g. Master Formula Record (MFR), Product Development Report (PDR), Product Development Lifecycle Management (PDLM) documents, Protocols & Reports.