Are you looking for a career that matters?
We believe every person deserves a chance for a healthy life, free from illness and full of possibility. We see a world full of healing, with viable care options available to those with limited choices today. We envision new ways of providing physicians, pharmacists and nurses with technologies that not only treat chronic diseases, but also work to prevent them. We’re looking for team members who are motivated to learn, grow and innovate, while making a meaningful difference for millions of people around the world.
[...] Roles & Responsibilities: -
- To review the Master protocols and take approval of superior.
- To review the Standard Operating Procedure (SOP) according to the current regulatory requirements and forward to Department Head for final approval.
- To ensure the clean environment for sterile preparation by implementing the Good Manufacturing Practice (GMP) norms as per the international standards and guidelines.
- To review the yearly calendar such as calibration and Performance Qualification (PQ) Calendars.
- To ensure calibration and validation of instruments in microbiological laboratory.
- To review and approve reports of microbiological validations.
- To establish test protocol designs for scientific validation of test methods, equipment and instruments used in testing or monitoring aspects of product quality.
- To ensure that BET, Bioburden and Sterility test are conducted as per the schedule.
- To ensure other periodic microbiological tests as per Standard Operating Procedure (SOP).
- To capture the abnormalities in the process, system or documents and resolve them according to Quality management system.
- To carry out investigation in case of Out of specifications (OOS) and take the corrective and preventive actions (CAPA).
- To suggest effective Corrective and Preventive Action (CAPA) for the abnormalities observed and ensure its implementation.
- To keep track of regulatory commitments and ensure fulfilment of the same.
- To periodically conduct the training programmes for the personnel working in the clean room to ensure the effectiveness of the same on Good Manufacturing practices, Good Laboratory Practices, health, hygiene and maintenance of clean room environment by following the right procedure.
- To look after the administration of personnel to ensure that they are adequately supported, trained, developed and adhere to the quality standards.
Baxter is committed to working with and providing reasonable accommodations to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application or interview process, please send an e-mail to Americas_TTA@baxter.com and let us know the nature of your request along with your contact information.