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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.

Position: Supervisor, R&D Compliance

Department: Quality Control

Location: Ahmedabad, Gujarat, India

Job Description:

  • Assessment of existing quality system, identification of gaps and improvement of same
  • Detail assessment of plant and R&D investigation related to product, process, and system.
  • Detail assessment of change management system.
  • Risk analysis, Trending of error, CAPA identification & implementation
  • Handling of all external audits
  • Conduct effective internal audit in ADL & F&D laboratories
  • Evaluation of the analytical development data
  • Monitoring of development as per AQbD approach
  • Evaluation of the analytical method verification and validation as per ICH requirement.
  • Monitoring of development as per the QbD approach
  • Assessment of product development approach as per the PDLM requirement.
  • Assessment of technology transfer documents
  • Detail compendia assessment

  • Quality assessment of products developed by CRO
  • Assessment of regulatory query responses
  • Training & knowledge enhancement of the team
  • Design & Authorization of SOP’s
  • Ensuring Compliance to SOP’s
  • Adoption of QGP (Procedures integration with Baxter systems)
  • Global IT tools

Reasonable Accommodations

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.

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