Qualified Person

3 weeks ago

Ware, United Kingdom 1054 GlaxoSmithKline Services Unlimited Full time

We have new opportunities for Qualified Persons (QPs) to join our Quality Assurance (QA) team at our Ware R&D and Harlow sites. As a QP you will perform the quality assurance activities and quality oversight of the GMP functions performed within Pharmaceutical Research & Development processes (including batch-release for manufactured product for clinical trial purposes).
 

Responsibilities (include)..,

Provide Qualified Person certification (as defined in EU directive 2001/20/EC, regulation 536/2014, Article 51 of Directive 2001/83/EC and UK equivalents) and perform QP release of a range of bulk and primary packed Investigational medicinal products.

Ensure compliant operations are in place to allow for UK certification of batches of Investigational Medicinal Products and assure products meet regulatory requirements.

Maintain knowledge of legislation changes applicable to QP Certification (including evaluate impact and propose mitigation for compliant management and/or introduction).

Provide QP advice to GSK project teams, external collaboration partners and sponsors concerning acquisitions and unlicensed medicines to reduce regulatory risk to GSK and ensure information and other QP assurances are obtained (as required).

Build and maintain internal and External business relationships (communicating and interacting at various levels internally and externally). Incorporate effective processes in Product Quality Pharma R&D to provide oversight of manufacturing facilities (pilot plant and/or clinical packaging and distribution).

Participate in audits/investigations (eg; Quality Investigations, customer complaints and vendor complaints) and recommend corrective and preventative actions (and follow up on the implementation of those recommendations).

About You:

You will be a Qualified Person (QP) – this is key to delivery in this role. Your QP qualification must be recognized in the UK.

As this role is multi-faceted and collaborates with a wide variety of on-site production and operations teams, you will also be self-motivated with strong experience of working in quality at a sophisticated manufacturing site. You will be resilient and calm, with strong communication skills.

About Ware & Harlow R&D Sites:

We have vacancies as part of team expansion at both our Ware R&D site and our Harlow site (based in Hertfordshire/Essex). Both sites are involved with the Research and Development of GSK’s medicines and the manufacturing and/or packaging and certification for clinical-trial purposes.

CLOSING DATE for applications: Tuesday 28th of May 2024 (COB).

Basic Qualifications:

Qualified Person (QP) - stated on a current UK Manufacturer’s/Importer’s licence

Relevant experience

Benefits:

GSK offers a range of benefits to its employees, which include, but are not limited to:

Competitive base Salary

Annual bonus based on company performance

Opportunities to partake in on the job training courses

Opportunities to attend and partake in industry conferences

Opportunities for support for professional development/chartership

Access to healthcare and wellbeing programmes

Employee recognition programmes

Hybrid (onsite/remote) working within GSK policies (post training period)

If you would like to learn more about our company wide benefits and life at GSK we would suggest looking at our webpage .

Why GSK?

Uniting science, technology and talent to get ahead of disease together.

GSK is a global biopharma company with a special purpose – to unite science, technology and talent to get ahead of disease together – so we can positively impact the health of billions of people and deliver stronger, more sustainable shareholder returns – as an organisation where people can thrive. We prevent and treat disease with vaccines, specialty and general medicines. We focus on the science of the immune system and the use of new platform and data technologies, investing in four core therapeutic areas (infectious diseases, HIV, respiratory/ immunology and oncology).

Our success absolutely depends on our people. While getting ahead of disease together is about our ambition for patients and shareholders, it’s also about making GSK a place where people can thrive. We want GSK to be a place where people feel inspired, encouraged and challenged to be the best they can be. A place where they can be themselves – feeling welcome, valued, and included. Where they can keep growing and look after their wellbeing. So, if you share our ambition, join us at this exciting moment in our journey to get Ahead Together.

As an Equal Opportunity Employer, we are open to all talent. In the US, we also adhere to Affirmative Action principles. This ensures that all qualified applicants will receive equal consideration for employment without regard to neurodiversity, race/ethnicity, colour, national origin, religion, gender, pregnancy, marital status, sexual orientation, gender identity/expression, age, disability, genetic information, military service, covered/protected veteran status or any other federal, state or local protected class*(*US only).

We believe in an agile working culture for all our roles. If flexibility is important to you, we encourage you to explore with our hiring team what the opportunities are.

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