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Site Name: UK - Essex - Harlow
Posted Date: Aug 30 2023

Qualified Person

Closing Date for Applications – 13th September (COB)

We have a new opportunity for a Qualified Person to join our team on a permanent basis at Harlow. The successful person will perform the quality assurance activities and quality oversight of the GMP functions performed within Pharma R&D. As a Qualified Person, is personally accountable to conform to the legal regulatory requirements as stated in Clinical trials - Directive 2001/20/EC, Article 62(1) of Regulation (EU) No. 536/2014, article 4 of Delegated Regulation 1569/2017, Article 51 of Directive 2001/83/EC and Statutory Instrument 2004/1031 (43. (2) dependent on location.

We create a place where people can grow, be their best, be safe, and feel welcome, valued and included. We offer a competitive salary, an annual bonus based on company performance, healthcare and wellbeing programmes, pension plan membership, and shares and savings programme.

We embrace modern work practises; our Performance with Choice programme offers a hybrid working model, empowering you to find the optimal balance between remote and in-office work.

Discover more about our company wide benefits and life at GSK on our webpage Life at GSK | GSK

In this role you will

• 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 a compliant operation is in place to allow for UK certification of batches of Investigational Medicinal Products and assure products meet regulatory requirements and that they conform to regulatory submissions.
• Maintain knowledge of legislation changes and proposals applicable to QP Certification, evaluate impact and propose mitigation for their compliant management and/or introduction.
• Provide QP advice and consultancy working with GSK project teams, external collaboration partners and external sponsors to reduce regulatory risk to GSK and ensure information and other QP assurances are obtained (as required).
• Build and maintain effective internal GSK and External business relationships. communicate and interact at various levels internally and externally to GSK. Develop and incorporate effective processes and procedures in Product Quality Pharma R&D and may contribute to business processes and procedures outside Product Quality Pharma R&D including coaching, mentoring, or training.
• Participate in routine or regulatory audits and investigations, such as Quality Investigations, customer complaints and vendor complaints and make recommendations for corrective and preventative actions, and to follow up on the implementation of those recommendations.

Why you?

Qualifications & Skills:

We are looking for professionals with these required skills to achieve our goals:

• Science degree and extensive experience in pharmaceutical manufacturing and quality operations.
• Eligible to act as Qualified Person in the UK
• Experience with the QP certification of major dose forms such as Tablets, aseptic sterile manufacture and biopharm products
• Experienced in Regulatory Inspections
• Broad knowledge of quality management
• Capable of working in multi-disciplinary teams

Preferred Qualifications & Skills:

If you have the following characteristics, it would be a plus:

• Previous experience of working with external partners.
• Experience in QP certification of Investigational Medicinal products.

Why Us?

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 organization where people can thrive. Getting ahead means preventing disease as well as treating it, and we aim to positively impact the health of 2.5 billion people by the end of 2030.

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 workplace where everyone can feel a sense of belonging and thrive as set out in our Equal and Inclusive Treatment of Employees policy. We’re committed to being more proactive at all levels so that our workforce reflects the communities we work and hire in, and our GSK leadership reflects our GSK workforce.

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.

Should you require any adjustments to our process to assist you in demonstrating your strengths and capabilities contact us on [email protected] or 0808 234 4391. Please note should your enquiry not relate to adjustments, we will not be able to support you through these channels

As you apply, we will ask you to share some personal information which is entirely voluntary. We want to have an opportunity to consider a diverse pool of qualified candidates and this information will assist us in meeting that objective and in understanding how well we are doing against our inclusion and diversity ambitions. We would really appreciate it if you could take a few moments to complete it. Rest assured, Hiring Managers do not have access to this information and we will treat your information confidentially.

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