Assoc I, Qms

Year    GJ, IN, India

Job Description

This is where you save and sustain lives




At Baxter, we are deeply connected by our mission. No matter your role at Baxter, your work makes a positive impact on people around the world. You'll feel a sense of purpose throughout the organization, as we know our work improves outcomes for millions of patients.


Baxter's products and therapies are found in almost every hospital worldwide, in clinics and in the home. For over 85 years, we have pioneered significant medical innovations that transform healthcare.


Together, we create a place where we are happy, successful and inspire each other. This is where you can do your best work.


Join us at the intersection of saving and sustaining lives--where your purpose accelerates our mission.

To prepare and update the error free and user-friendly documents. To facilitate Internal Quality Audits to ensure the compliance for all systems and procedures. To verify process and systems to ensure these are complying with standard operating procedures (SOPs) and current regulatory requirements and guidelines. To initiate the change in process, equipment or facility as per requirement in line with Standard Operating Procedure (SOP). To verify & ensure Corrective & Preventive Actions (CAPA) against audit observations are implemented effectively. To initiate & investigate Quality Management System (QMS) elements such as non-conformance (NCR), Corrective & Preventive action (CAPA) for Utility in Track wise. To attend and implement training related to Quality Management System (QMS) and current Good Manufacturing Practice (cGMP) and ensure the on-time training completion of team. To check & verify that data integrity is being maintained at all levels by frequent GEMBAs. To escalate issues or concerns to Supervisor, department head. To act as Author and prepare Quality Management System (QMS) related documents such as Standard Operating Procedure (SOP), Exhibit, Standard Format, User requirement specification, qualification protocol, etc. in TcU and ensure the documents are in line with current Good Manufacturing Practice (cGMP) requirements. To track & comply with Quality Key Performance Indicators (KPIs) metrics & take corrective action to ensure such performance metrics are within the target achievement. To face an internal or external current Good Manufacturing Practice (cGMP) regulatory audits & respond to the auditors' queries. Also ensure audit preparedness in the function

Equal Employment Opportunity




Baxter is an equal opportunity employer. Baxter evaluates qualified applicants without regard to race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, protected veteran status, disability/handicap status or any other legally protected characteristic.

Reasonable Accommodations





Baxter is committed to working with and providing reasonable accommodations to individuals with disabilities globally. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application or interview process, please click on the link here and let us know the nature of your request along with your contact information.

Recruitment Fraud Notice





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Job Detail

  • Job Id
    JD3999036
  • Industry
    Not mentioned
  • Total Positions
    1
  • Job Type:
    Full Time
  • Salary:
    Not mentioned
  • Employment Status
    Permanent
  • Job Location
    GJ, IN, India
  • Education
    Not mentioned
  • Experience
    Year