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.
Quality Assurance Specialist
SUMMARY
The Quality Assurance Specialist ensures product quality at Sandyford, supporting high standards and new products.
Essential duties and responsibilities
-
Ensure compliance with cGMP, corporate standards, Baxter Quality Systems (PQS), site policies/procedures, regulatory requirements, and industry standards.
-
Participate in cross-functional teams to provide consultative support on quality-related issues and ensure timely resolution of discrepancies.
-
Manage and review Merlin Component Files and Finished Product Codes.
-
Coordinate the Annual Stability Review Programme and maintain stability data.
-
Coordinate the Change Control System and NCR Management, ensuring accurate implementation and administration.
-
Investigate customer complaints and quality defects, implementing corrective and preventive actions (CAPAs) as necessary.
-
Quality approval of environmental monitoring results and preparation of trend reports.
-
Provide technical input on Change Control evaluations and impact assessments.
-
Prepare Deviation and Quality Assurance trend reports, as well as Key Performance Indicators.
-
Ensure change controls are aligned with procedures and maintain a validated state.
-
Assist in compiling the Quality Management Review (QMR).
-
Manage the Recall Process with Quality Management.
-
Support Supplier Quality Management and raise SCARs with suppliers as needed.
-
Facilitate Annual Product Record Reviews (APQR) and ensure timely completion of final reports.
-
Support the introduction of new products and review qualification/verification protocols.
-
Ensure the timely release of equipment, facilities, and systems following test protocols.
-
Act as a key member of the Quality Risk Management team to identify and implement continuous improvement opportunities.
-
Support trending and compilation of investigation/system reports and customer complaints.
-
Ensure inspection readiness and participate in site self-inspections, Gemba walks, and audit programs.
-
Manage and maintain the Documentation Management System, ensuring operational documentation is compliant and up-to-date.
-
Support the implementation of the Risk Management process and coordinate risk assessments.
Education and/or experience
-
Degree or equivalent experience in Science or a related field.
-
Proven experience working in a GDP/GMP environment, preferably with a minimum of 2-3 years’ experience.
-
Experience in dealing with Regulatory Compliance is desired.
-
Strong problem-solving and investigation skills are beneficial.
Skills
-
Meticulous attention to professional standards.
-
Ability to respond well to time constraints and work under pressure.
-
Strong attention to detail and professional standards.
-
Highly motivated self-starter and great teammate.
-
Excellent organisational, coordination, and communication skills.
-
Ability to handle a variety of specific tasks in a dynamic, fast-paced, and dedicated environment.
-
Good influencing and interpersonal skills.
What are some of our benefits of working at Baxter?
-
Competitive total compensation package
-
Professional development opportunities
-
High importance placed on work-life balance
-
Pension
-
Health Insurance
-
Life Assurance
-
Baxter is committed to growing and developing their workforce – you can read more about our specific values here https://www.baxter.com/careers/inclusion-diversity.
We offer accommodations for individuals with disabilities during the application, interview, job tasks, and employment benefits. Contact us for assistance.
We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.
#IND-UKIRE
#JOBSIE
#IND-UKCOM
#IND-UKOPS
#LI-BAXGEN
#LI-LR1
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.
