Process Senior Sme - Oxford, United Kingdom - BAXTER

BAXTER

Verified Company

Oxford, United Kingdom

1 week ago

Posted by:

Tom O´Connor

beBee Recruiter

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.

Summary

Essential Duties and Responsibilities

Act as quality champion in the operational team, support and conduct investigations to support the Operational leadership team
Be responsible of completion of operational investigations within the QMS in conjunction with Quality colleagues Attend the Compliance meetings and QMR Use DMAIC tools and ensure effective and timely communication to impacted stakeholders Support Internal Audits in line with the Internal Audit Schedule
Support Corporate, external Regulatory and Customer audits through provision of requested documentation, records and information in a timely manner. TrackWise 8 NCR/CAPA/CQI/CPI (TW8)/TcU System User Fully support the Quality Policy and Business Objectives by building quality into all aspects of work
Be a change control owner, as well as conduct Manufacturing Impact Assessments within the TrackWise 8 (TW8) Change Control process. Own, write, and update SOPs where required.

Key Stakeholders:
Site Manager Quality Function Local site Management Team Engineering

Qualifications

Experience of QMS and GMP in a regulated industry
Aseptic manufacturing environment experience, familiarity with EU GMP Annex 1 preferred
Knowledge of isolator, RABS and VHP technology preferred
Excellent interpersonal skills with ability to interface well with other departments

- knowledge of such principles as GMPs, cleanroom requirements and automation

Be selfmotivated, have good interpersonal skills, capable of analyzing and solving problems through innovative thought and experience

IND-UKOPS

Reasonable Accommodations

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.

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