Production Specialist

4 weeks ago

Stockport, United Kingdom 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.

Summary

To provide and facilitate operations as a Production Specialist (systems, processes and equipment) to the compounding team (Ops/Eng) in the support of Quality investigations.

Essential Duties and Responsibilities

Quality champion in the operational team, support and conduct investigations to support the Operational leadership team.

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 collaborators

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) System User

Fully support the Quality Policy and Business Objectives by building quality in to all aspects of work.

Conduct Manufacturing Impact Assessments within the TrackWise 8 (TW8) Change Control process

Education and/or Experience

Excellent interpersonal skills with ability to interface well with other departments.

Must have knowledge of such principles as GMPs, cleanroom requirements and automation.

Must be self-motivated, have good interpersonal skills, capable of analyzing and solving problems through innovative thought and experience.

Ability to collaborate with cross-functional teams simultaneously.

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.

What are some of the benefits of working at Baxter?

Competitive total compensation package

Professional development opportunities

High importance placed on work life balance

Commitment to growing and developing an inclusive and diverse workforce

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