Qualified Person/responsible Person

2 months ago

Newbury, United Kingdom BAXTER Full time

**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.

**This is where your attention to detail addresses challenges**

As a QP, you are unafraid of navigating through necessary internal processes to facilitate a product you deeply believe in. If needed, you can absorb and act on complex procedures and data and train your team or peers. You take pride in getting things done quickly without sacrificing safety or quality.

**Your Team at Baxter**

The Quality function values both working together as a team and independently. We draw energy from working in a plant or an office where there are opportunities to collaborate. As the company evolves, so does how our team approaches work as it strives to build top-of-the-line products.

We build relationships with each other to get work done. Building these relationships is easy because we all share common traits of being reliable, ethical, and caring. We lean on our colleagues for their expertise and hold each other accountable. We feel empowered to speak up when there's a new insight or opportunity to improve something. This open dialog builds trust within the team and helps create a better product for our customers.

**Tasks include**:

- Responsible for ensuring certification of imported batches for release to the UK market, Certification is permitted under the terms of the manufacturing/importation authorization (MIA), Any additional duties and requirements of UK national legislation are complied with, and Certification is recorded in a register or equivalent document.
- All activities associated with the manufacture and testing of the medicinal product have been conducted per the principles and guidelines of EU GMP
- The entire supply chain of the medicinal product, starting from the manufacturing sites of the starting materials and components and including all parties involved in any manufacturing and importation activities of the medicinal product, is documented and available for the QP
- The active substances used in the manufacturing of the finished products have been manufactured following GMP and, where required, imported and distributed under Good Distribution Practices (GDP)
- Finished product quality control (QC) test data complies with the registered Finished Product Specification
- named Responsible Person (RP) and Responsible Person for Import (RPi) on WDA(H) and fulfil all requirements of the role in accordance with MHRA Regulations (Human Medicines Regulations 2012) and other such guidelines published by the Medicines and Healthcare products Regulatory Agency (MHRA)

**What you'll bring**
- Degree in Pharmacy, Chemistry, Biology, or another relevant science, supplemented such that the education requirements of the EU Directive 2001/83/EEC are fulfilled as required to be eligible to operate as a Qualified Person in the UK
- Being eligible to be a Qualified Person in the UK
- At least 2 years of experience as UK QP certification for imported products, RP/RPi requirements for WDA(H), Import/ Export activities, 3PL partnerships, external storage sites

**What we offer**
- home based full-time permanent contract, Monday-Friday from 9:00 am to 5:00 pm with some flexibility. The role requires to travel to our Liverpool and Northampton sites on a regular base, liaising with operations team
- Market competitive salary
- 10% performance bonus
- Single cover for Private Medical Insurance
- Car Benefit / car allowance
- Professional development opportunities
- High importance placed on work life balance
- A workplace environment that is inclusive, encouraging, and diverse
- Access to retail discounts including Blue Light Card

IND-UKOPS

IND-UKCOM

**Reasonable Accommodations**

**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.

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