Senior Associate, Production QMS
Senior Associate, Production QMS
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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. Youll feel a sense of purpose throughout the organization as we know our work improves outcomes for millions of patients.
Baxters 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 liveswhere your purpose accelerates our mission.
- To prepare and review manufacturing investigations related to NCR /OOS/OOT/OOL/market complaints to identify the root cause and implementation of appropriate CAPA.
- To prepare and review risk assessment for associated QMS element & ensure completion of risk assessment in timely manner.
- To initiate and review Change Control for any changes execution and Change Control closure in timely manner.
- To handle and review Document change request/ Change control and impact assessment of the cross functional department.
- Handling of QMS activities in Track wise software.
- To prepare and review Standard Operating Procedure (SOP) Exhibit Standard Format in TcU and ensure the documents are in line with current Good Manufacturing Practice (cGMP) requirements
- To escalate any delay in investigation or QMS elements to supervisor & ensure closure of the same within defined timeline. T complete training on assigned SOPs in BAXU system in timely manner & ensure completion of such training completion by team and coordinate with Training and Development department for initiation effectiveness and closure of training.
- To track all open QMS elements & ensure closure of such elements with effective CAPA within defined timeline.
- To check data integrity & compliance of all processes & systems is being maintained at all levels by frequent GEMBA.
- To face internal or external current Good Manufacturing Practice (cGMP) regulatory audits & respond to the auditors queries. Also ensure audit preparedness in the function.
- To inform supervisor/individual regarding a safety/ Hazard concern in area.
- To perform task assigned by department head time to time.
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
Baxter has discovered incidents of employment scams where fraudulent parties pose as Baxter employees recruiters or other agents and engage with online job seekers in an attempt to steal personal and/or financial information. To learn how you can protect yourself review our Recruitment Fraud Notice.
Required Experience:
Senior IC
Employment Type
Full-Time
