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Sr Quality Engineer, Validation

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Baxter

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Location:
India , Ahmedabad

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Category:
IT - Administration

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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 prepare, execute, compile and review protocols of equipment, utility, process validation, cleaning validation, and facility qualification.
  • To coordinate with cross functional teams of all departments for execution of all validation activities & inform to Manager regarding any non-conformity from planning and execution.
  • To prepare monthly and annual calendars for various periodic qualification/validations & get it reviewed by Manager and approved by Manager.
  • To monitor the QMS elements like Change Control Management, Corrective and Preventive Action, OOS, non-conformance related to the validation activity and prepare investigation report and ensure proper closure of the QMS documents in Track wise.
  • To review the scheduled validation activity as per calendar and send it to the cross functional & PPA department in advance for execution planning before the scheduled date.
  • To ensure samples withdrawal during process validation & keep Manager updated about any non-conformity.
  • To ensure compilation of executed protocols is done online (as applicable) and observation sheets for process validation and other qualifications are duly filled & signed. To ensure the CFS closure of respective documents.
  • To co-ordinate with projects and other cross functional dept. for prior information on new equipment installation and to prepare the protocol in advance, followed by new equipment qualification and get it reviewed by the Manager.
  • To attend training of each protocol before execution of any validation and qualification activity.
  • To collect data & compile summary report for submission to International Regulatory Affairs (IRA) for queries and ANDA.
  • To update the protocols as per current regulatory requirement to improve the validation documents.
  • To prepare VMP as per regulatory guideline or any audit compliance requirement and provide it to Manager for review & approval.
  • To keep the validation document updated from GMP aspect as per regulatory expectation.
  • Planning and execution of validation activities associated with QMS elements.
  • To inform the activity or issues which might occur during the shift's validation activities through daily meeting.
  • To review and approve documents related to Validation activities and other documents related to Operation.
  • To assist/participate during internal or external inspection.
  • Timely completion of assigned trainings.
  • To be vigilant of safety aspects and record hazard or any near miss in the provided portal.
  • Any additional responsibility as assigned by the Manager.

Requirements:

  • To prepare, execute, compile and review protocols of equipment, utility, process validation, cleaning validation, and facility qualification.
  • To coordinate with cross functional teams of all departments for execution of all validation activities & inform to Manager regarding any non-conformity from planning and execution.
  • To prepare monthly and annual calendars for various periodic qualification/validations & get it reviewed by Manager and approved by Manager.
  • To monitor the QMS elements like Change Control Management, Corrective and Preventive Action, OOS, non-conformance related to the validation activity and prepare investigation report and ensure proper closure of the QMS documents in Track wise.
  • To review the scheduled validation activity as per calendar and send it to the cross functional & PPA department in advance for execution planning before the scheduled date.
  • To ensure samples withdrawal during process validation & keep Manager updated about any non-conformity.
  • To ensure compilation of executed protocols is done online (as applicable) and observation sheets for process validation and other qualifications are duly filled & signed. To ensure the CFS closure of respective documents.
  • To co-ordinate with projects and other cross functional dept. for prior information on new equipment installation and to prepare the protocol in advance, followed by new equipment qualification and get it reviewed by the Manager.
  • To attend training of each protocol before execution of any validation and qualification activity.
  • To collect data & compile summary report for submission to International Regulatory Affairs (IRA) for queries and ANDA.
  • To update the protocols as per current regulatory requirement to improve the validation documents.
  • To prepare VMP as per regulatory guideline or any audit compliance requirement and provide it to Manager for review & approval.
  • To keep the validation document updated from GMP aspect as per regulatory expectation.
  • Planning and execution of validation activities associated with QMS elements.
  • To inform the activity or issues which might occur during the shift's validation activities through daily meeting.
  • To review and approve documents related to Validation activities and other documents related to Operation.
  • To assist/participate during internal or external inspection.
  • Timely completion of assigned trainings.
  • To be vigilant of safety aspects and record hazard or any near miss in the provided portal.
  • Any additional responsibility as assigned by the Manager.
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:
May 05, 2026

Employment Type:
Fulltime
Work Type:
On-site work
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