- Ensure the effective implementation of the Baxter Quality Management System in Compounding Facilities, in compliance with Global and local Regulatory requirements, by quality data monitoring and analysis (e.g. data collection & analysis of Quality KPIs/Metrics, for Global Compounding (GC) Management Reviews and PRO Site model)
- Quality System coordinator for EMEA & Global Compounding Quality documentation including: Impact and Implementation assessment process of corporate documents, documentation issuance and management
- BAXU training course(s) update and assignment,
- SharePoint and EMEA QS repositories maintenance
- Coordination (data collection & analysis) of Quality KPIs/Metrics, for Global Compounding quality needs and management review
- Identify, track, trend and report Key Performance Indicators (KPIs) for processes under role responsibility to identify opportunities for improvement.
- Coordination of escalation process to Management
- Qualified Trainer for NCR/CAPA and Change Control processes.
- Support the execution of timely deviations and complaints investigations;
- Ensure timely completion of all Quality System commitments;
- Proactively identify and support implementation of continuous improvement opportunities;
- Other duties in support of Compounding Quality Systems as required, including support to Regional/Global Compounding
- Qualified to degree level or equivalent in Pharmaceutical, Biotechnology, Chemistry, Microbiology / Engineering or at least 3 years' experience of supporting, improving and maintaining Quality Systems and processes.
- At least 3 years in a regulated environment
- Motivated and enthusiastic about Quality
- Experience in implementing and maintaining quality systems in a regulated environment, including document control, change control, nonconformance management, validation.
- High level of proficiency in IT systems, software tools to manage Quality Systems and data analysis and visualization applications (required).
- Experience of problem solving using Root Cause Analysis techniques such as GEMBA, 5 Whys, Cause and Effect desired
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Quality Systems Specialist - Thetford, United Kingdom - Baxter
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
Compounding have a great opportunity for a Quality Systems Specialist to join the team. Reporting the EMEA Region Quality Systems Manager, you will ensure continuous compliance of Compounding facilities, in compliance with Global and local Regulatory requirements, by quality data monitoring and analysis. This role can be based in the UK at either Thetford, Stockport, Croydon or Oxford. We operate on a hybrid model under BAXFLEX meaning a minimum of 3 days on site and 2 from home if you wish.
Main duties & responsibilities
What are we looking for?
What happens next?
Your application will be reviewed by our Talent Acquisition team. If deemed suitable you will receive a hirevue assessment to complete online which acts as a first stage interview. This is a mixture of written and video responses that allows us to get to you know you a little better. We will review this along with the hiring manager and if successful you will be invited for an interview with the Quality Systems Manager.
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