Regulatory and Quality Compliance Expert

2 weeks ago


United Kingdom Baxter Healthcare Full time

At Baxter, we are deeply connected by our mission. 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.
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. We operate on a hybrid model under BAXFLEX meaning a minimum of 3 days on site and 2 from home if you wish.
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.
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 d egree level or equivalent in Pharmaceutical, Biotechnology, Chemistry, Microbiology / Engineering or at least 3 years’ experience of supporting, improving and maintaining Quality Systems and processes.
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
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.
#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 . 133977 Baxter Healthcare Ltd|Pharmacy Services, Caxton Way|Thetford|Norfolk|IP24 3SE|United Kingdom #J-18808-Ljbffr



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