Senior CQA Specialist/ Deputy Responsible Person

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.

Senior CQA Specialist/ Deputy Responsible Person

Job Description

Baxter are seeking a Senior CQA Specialist/Deputy Responsible Person to be based out of our National Distribution Centre in Northampton. This role will ensure that the United Kingdom (UK) Quality Country Operations and Supply Chain (QCOSC) are legally compliant and in line with UK legislation & regulatory authority guidance. This role will also act as the Deputy Responsible Person for the Wholesale Dealers Licence and contact with the MHRA.

Duties & Responsibilities

• Perform system release of product for distribution, aligned with local and European regulations and Baxter policies

• Post-market Surveillance – Support management of customer complaints (final review of response letters)

• Support the Quality Management System ensuring site-wide local systems are in compliance with Baxter Corporate and Regulatory requirements

• Participate in the internal and external audit programme and any resulting corrective/preventive actions. Represent Baxter at inspections by regulatory authorities as required. Ensure local procedures are in place to support this

• Act as a Deputy Responsible Person performing the duties of the Responsible Person as a back-up function in their absence, in accordance with MHRA Regulations (Regulation 45 of the Human Medicines Regulations 2012) and Guidelines of GDP of Medicinal Product for Human Use, 2013/C 343/01 and other such guidelines published by the Medicines and Healthcare products Regulatory Agency (MHRA)

What experience are we looking for?

• At least 2 years, within healthcare or pharmaceutical environment with experience in distribution, and product release

• Must alreay be acting as a (Deputy) Responsible Person

• BSc or equivalent experience., preferably in a science, engineering on related discipline

What are some of our 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.

Baxter is committed to growing and developing an inclusive and diverse workforce – you can read more about our specific values here https://www.baxter.com/careers/inclusion-diversity.

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.

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