Quality Systems Specialist (UK/IRE/Nordics Compounding)Req # JR - 017238 Location Compton, England, United Kingdom Job Category Quality Control Date posted 06/10/2020
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We believe every person deserves a chance for a healthy life, free from illness and full of possibility. We see a world full of healing, with viable care options available to those with limited choices today. We envision new ways of providing physicians, pharmacists and nurses with technologies that not only treat chronic diseases, but also work to prevent them. We’re looking for team members who are motivated to learn, grow and innovate, while making a meaningful difference for millions of people around the world.
Baxter Compounding are recruiting for an enthusiastic individual with hands on experience of working to and implementing changes in a regulated Quality Management System environment such as the Pharmaceutical or Medical Device industries. You will be highly motivated to collaborate, challenge, innovate and improve procedures and processes to deliver simplicity and speed whilst maintaining standards of compliance.
As an integral part of a centralised Quality function you will work closely with Quality and Operational teams at Baxter Compounding sites in the UK, Ireland and Sweden.
This role will support the maintenance, performance and improvement of the Quality Management System across the Compounding sites through the analysis of data to ensure areas of non-conformance and opportunities for improvement are identified and addressed in a timely manner to meet goals and performance objectives.
The role reports to the Quality Systems Manager (UK, Ireland and Nordics) and will be nominally based at one of the compounding sites, with some home working and travel to UK, Ireland and Sweden as required.
The role supports the consistent application of the Baxter Quality System across the UK, Ireland and Nordics Compounding organisation in the areas of:
Quality Management Review (QMR)
- Support scheduled completion of Quality Management Reviews across the UK, Ireland and Nordic network through trending and reporting of applicable Quality Management System data.
- Identify, track, trend and report on performance metrics to identify opportunities for improvement.
- Support timely completion of actions arising from QMR.
- Support maintenance and communication of the annual Internal Audit schedule and Auditor Training Matrix across the UK, Ireland and Nordic cluster
- Support tracking, trending and analysis of audit findings and NCRs in TrackWise system ensuring cross site collaboration, initiation of corrective and preventive actions and timely closure.
- Support Internal, Corporate, external Regulatory and Customer audits across the network.
- Support network wide audit responses and progress changes to the Quality Management System in order to maintain regulatory compliance.
- Support progression of Complaints in TrackWise with assigned Owners to ensure timely assessment of risk and complaint closure.
- Support the trending, monitoring and reporting of Complaints data to facilitate Quality Management Review (QMR) and cross site continuous improvement opportunities
- Support update and maintenance of local Complaint Management procedures in line with Corporate, Compounding and Regulatory requirements.
Nonconformance and Corrective & Preventive Action Processes
- Support initiation, investigation, assessment of risk and progression of identified events in the NCR / CAPA / CPI / OOL /SCAR systems including TrackWise with assigned Owners to ensure timely closure.
- Support the trending, monitoring and reporting of NCR / CAPA / CPI / OOL / SCARs to facilitate Quality Management Review (QMR) and cross site continuous improvement opportunities.
- Support update and maintenance of local Non-Conformance and Corrective & Preventive Action Management procedures in line with Corporate, Compounding and Regulatory requirements.
- Support maintenance of effective change control process to ensure all changes are fully documented and impact of change evaluated across the UK, Ireland and Nordic Compounding network.
- Support trending, monitoring and analysis of Change Control metrics to measure process performance.
- Generate and maintain Change Control impact assessment tools, workflows and procedures to ensure all impacted products, processes, procedures, stakeholders and sites are evaluated and approved prior to initiating a change.
- Track and monitor the progress of initiated Change Controls to ensure timely completion to plan.
- Fully support the Quality Policy, Business goals and objectives by building quality in to all aspects of work.
- Support country / local initiatives and projects within the Compounding network eg. Integration projects, Value Improvement Projects, cross site changes, shared application development, commercial ventures and tenders.
- Support development and delivery of Quality Management Systems training.
- Identify new, or changes to existing, processes and systems to improve effectivity and efficiency of the Quality System across the UK, Ireland and Nordic network, whilst maintaining compliance with Corporate and Regulatory requirements.
- Adhere to Environmental Health & Safety (EHS) policies, procedures and requirements.
Qualification and Experience
- A degree level or equivalent in Science (Biotechnology, Chemistry, Microbiology, Medical) preferred.
- Extensive experience of supporting, improving and maintaining Quality Management Systems and processes in a regulated environment essential, with a working knowledge of current EU and UK GMP requirements (EU GMP Annex 1) preferred.
- Strong analytical and problem-solving skills with experience of Root Cause Analysis and critical thinking abilities.
- Experience in Risk Management including analysis of product, process and system risks.
- Working knowledge and hands on experience of software tools to manage Quality Systems processes such as TrackWise, Agile, MasterControl, QPulse beneficial.
- Strong presentation, communication and negotiating skills, able to work with all levels of the organisation.
- Intermediate to advanced proficiency in Word, Excel, PowerPoint.
- Approximately 20% travel to Compounding sites within the network will be required.
- Full clean driving licence.
- Fluent in written and spoken English.
Baxter is committed to working with and providing reasonable accommodations to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application or interview process, please send an e-mail to Americas_TTA@baxter.com and let us know the nature of your request along with your contact information.