Supr, QA Qms

1 week ago


Ahmedabad, Gujarat, India BAXTER Full time

This is a place where you contribute to saving and improving lives
Being part of Baxter means being driven by a shared purpose. No matter what you do within Baxter, your actions have a positive impact on individuals globally.

You will experience a sense of fulfillment throughout the organization knowing that our efforts lead to better outcomes for millions of patients.

Baxter's innovative products and therapies are present in hospitals worldwide, as well as in clinics and homes. With over 85 years of experience, we have been at the forefront of medical advancements that revolutionize healthcare.

Together, we establish an environment where we thrive, succeed, and motivate each other. This is where you have the opportunity to excel.

Join us at the intersection of preserving and enhancing lives—where your dedication drives our mission.

  • Supervising all QMS-related activities daily and updating the QA Head accordingly.
  • Ensuring closure of all QMS elements related to batch release and production dispatch in collaboration with various departments.
  • Ensuring compliance with quality metrics in line with Global Quality criteria.
  • Managing the functional budget and conducting regular monitoring.
  • Holding daily department meetings, reviewing weekly or monthly activities, and reporting to the QA Head.
  • Ensuring effective completion of Nonconformance (NCR), LBINV (OOS/OOT/OOL), and LIR investigation reports, taking necessary CAPA promptly when abnormalities are detected.
  • Approving Nonconformance (NCR), LBINV (OOS/OOT/OOL), and LIR investigation reports.
  • Notifying the QA Head of any anomalies or potential nonconformities identified during document reviews or plant visits.
  • Ensuring timely closure of Document Change Requests and Change Control Management as per site's Standard Operating Procedure.
  • Approving Document Change Requests and Change Control processes at the site.
  • Reviewing/approving QMS trends reports and ensuring action plans are in place for any adverse trends or recommendations.
  • Attending and representing the QMS team in cross-functional/zone meetings.
  • Facilitating training on new procedures and current guidelines to team members with input or validation from the QA Head.
  • Providing/ensuring training on QMS Trackwise modules for ID creation.
  • Assessing and approving risks related to nonconformities or abnormalities in processes, documents, or systems as per the Quality Management System.
  • Representing the QMS function in CAPA review board meetings, Management review meetings, and other management gatherings.
  • Participation as the QMS representative in internal/external audits and ensuring necessary audit and compliance assistance.
  • Assigning tasks to the team and ensuring seamless coordination within the team and with cross-functional teams.
  • Collaborating with the Operations Head or Plant Manager to halt production if Good Manufacturing Practices (GMP) norms or Standard Operating Procedure requirements are not adhered to.
  • Requesting feedback for improvement areas from the QA Head and implementing action plans accordingly.
  • Acting as a Good Manufacturing Practice (GMP) inspector in the plant.
  • Compiling data essential for management insights and submitting it to the QA Head.
  • Reporting any failures or anomalies to the QA Head promptly for resolution.

Reasonable Accommodations

Recruitment Fraud Notice


Baxter has encountered instances of job scams, where deceitful parties impersonate Baxter employees, recruiters, or representatives to interact with online job seekers and illicitly obtain personal and financial information.

To understand how you can safeguard yourself, please refer to our Recruitment Fraud Notice.

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