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
For research associate II in formulation R&D
Candidate need to have the experience with review of raw material packing material specifications and need to have Experience with preparation of specifications for regulatory filing and for the manufacturing plant
Candidate need to support the internal regulatory and external regulatory audits For the manufacturing units
Candidate Required to have the experience with regulatory submission query and requirements
Candidate should have experience with technology transfer document review.
Need to support for the process validation commercial batches for Baxter sites and CMO
Able to handle the stability batches execution and stability loading
Self knowledge enhancement and complaint related activities
Need to troubleshoot and An investigate the out of specification and out of trend result for the exhibit and the commercial batches
Able to support the submissions for the regulatory markets I need to have thorough knowledge on current guidelines for MHRA, EMEA, USFDA ICH guidelines
Need to identify the instrumentation calibrations and document the formulas related development and exhibition of batches.
For Formulation R&D Manager
Locations of the job : Ahmedabad
Candidate need to develop The trials by QBD approach for ANDA products
Candidate required to compile the development data and monitor the development rights required to ensure the development as per QPD approach
Need to perform the technology transfer of products for complex injectables and me to execute the exhibit batches
Identify and give training and enhancement to the team
Able to adopt GQP - Procedures integration with baxter
Candidate required to compile the development data and plan the technical feasibility experiments
For associate quality control reviewer
Location : Ahmedabad
Need to have experience with deviations OOS and Preparation of Sops Review as per the current regulatory guidelines
Able to conduct The tracking system for corrective and preventive actions
Before to carry out the good manufacturing practise inspection at the plant unable to drive the members on various regulatory guidelines
Able to conduct the technical training on CCN impact assessment
Able to handle the change control ensure the timely closure of CAPA
Able to train various aspects of good manufacturing practises And investigate with QMS elements