Supr, QA Qms

3 months ago

Ahmedabad Gujarat, India BAXTER Full time

**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 supervise all the activity related to QMS on daily basis and provide status update to QA Head.
- To ensure closure of all QMS element related to batch release and production dispatch in co-ordination with cross functions department.
- To ensure the quality metrics compliance as per Global Quality metrics requirement.
- To maintain functional budget & monitor the same on periodic basis.
- To conduct daily meetings with department and review weekly or monthly departmental activity and report the same to QA Head.
- To ensure Non-conformance (NCR), LBINV (OOS/OOT/OOL) and LIR investigation report is completed in effective manner, on time and effective CAPA is taken in case of any abnormality observed.
- To approve Non-conformance (NCR), LBINV (OOS/OOT/OOL) and LIR investigation report.
- To communicate if any abnormality or potential non-conformities observed during document review or plant visit to QA Head.
- To ensure that Document Change Request and Change Control Management is closed as per Standard Operating Procedure for site.
- To approve Document Change Request and Change Control of site.
- To review/approve the QMS trends report and ensure the action plan for any adverse trend or recommendation.
- To attend and represent the QMS team during cross functional meetings/zone meetings.
- To ensure training of new procedures and current guidelines is provided to team members after discussion or verification of matter with QA Head.
- To provide/ensure training for QMS Trackwise modules to create IDs.
- To assess and approve risk of non-conformity or abnormalities in process or documents or systems are captured and resolve them according to Quality Management System.
- To represent the QMS function in CAPA review board meetings, Management review meetings and/or any other management meetings.
- To represent the QMS function during internal/external audits and ensure required audit and compliance support.
- To allocate work to the team and ensure the co-ordination within team and across cross functional team.
- To halt the production in consultation with Operations Head or Plant Manager
- Manufacturing, if the GMP (Good Manufacturing Practices) norms and the Standard Operating Procedure requirements are not followed.
- To seek area of improvement from QA Head and implement action plan.
- To work as a Good Manufacturing Practice (GMP) inspector in the plant.
- To compile data required for management information and provide to QA Head.
- To communicate about any failure or abnormality notification to QA Head for their attention and seeking for the solution.

**Reasonable Accommodations**

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