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Design Quality

https://www.baxter.com/ Logo

Baxter

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Location:
India , Ahmedabad

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Category:
Quality Control

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Contract Type:
Not provided

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Salary:

Not provided
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Job Description:

This is where you make a difference in our patients’ safety. As a member of the Baxter Quality team, you will play an essential part in our mission of saving and sustaining lives. Quality is important throughout the entire product lifecycle and works collaboratively with all areas of the organization. Because Quality touches everything Baxter does, a role in Quality provides many opportunities for growth, learning and a successful career that has a daily impact on people’s lives.

Job Responsibility:

  • To participate in meetings with cross functional teams like Analytical, Regulatory, Quality, manufacturing, Contract Manufacturing Organization (CMO), Project management, Characterization team for on time review support
  • To participate in meetings with Contract Manufacturing Organizations (CMOs) & Contract Research Organizations (CROs) & contract Labs for on-time review support
  • Responsible for tech transfer meetings with External Site as a core team member from quality for analytical discussion
  • To review, approve and ensure Technology Transfer/Validation/Verification/Post- production studies documents to respective plants
  • To be a part of investigations and to perform investigations extensively to derive root cause and its corrective measures and preventive actions
  • Quality SME for risk analysis of GPRD studies
  • To review and approve change controls, NCR/SNCR, CAPA, Effectiveness checks, etc.
  • To carry out internal quality audits and perform GEMBA walks of R&D labs for compliance & betterment as per current regulations and GLP (Good Laboratory Practice)
  • To impart training to R&D team members on various aspects of GMP (Good Manufacturing Practice) and GLP (Good Laboratory Practice) guidelines and practices
  • To ensure that the development is carried out as per the latest QBD (Quality by Design) and PDLM concepts
  • To review ADL documents like specifications, method of analysis, method development, method validations, method transfer reports, stability sheets and ensure compliance as per ICH (International Council for Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use) and filing requirements as and when required

Requirements:

  • Having a good knowledge of injectable formulation - peptide/liposomes and complex generic molecules
  • Having a good knowledge of product development and life cycle management
  • Having a good knowledge of critical analytical techniques like LCMS, GCMS, HPLC, GC, IC etc.
  • Having a good knowledge of regulatory requirements for ANDA/NDA submissions
  • Having good experience of responding regulatory queries
  • Having good critical thinking ability to challenge and resolve the technical concerns related to submission studies
What we offer:
  • Support for Parents
  • Continuing Education/ Professional Development
  • Employee Heath & Well-Being Benefits
  • Paid Time Off
  • 2 Days a Year to Volunteer

Additional Information:

Job Posted:
March 22, 2026

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