Job Details
We are seeking a Qualified Person (QP) to join our QP Importation team in Market Supply and Distribution.
The role reports into a Quality Director and provides UK batch certification and release service to GSK’s Principal Trading Companies (PTCs) and Trading Partners. You will ensure compliance with the GMP aspects of the laws governing the importation of products into the EU / UK in relation to all batch-releases. As a member of the OQ team you will be able to work with a degree of autonomy making critical Quality decisions whilst mentoring and supporting colleagues. In addition to undertaking regular batch release activities you provide direct support for critical deviations (including attending incident management meetings). The role will involve regular interaction with cross functional colleagues so stake-holder management, whilst acting with the highest level of integrity, respect and transparency is critical.
Key Responsibilities (include..,):
Managing operations to allow EU/UK certification of batches of pharmaceutical products imported by the Principal Trading Company (PTC). This includes supporting management of any incidents to ensure supply sites have the information required to manage investigations and resolve incidents.
Ensure QP Importation operation is inspection ready and participate in regulatory inspections of the QP certification process on behalf of the PTC.
Perform Audits of the importation supply-chain (compliant to GMP, GDP and MIA authorization).
QP certify all batches of pharmaceutical products imported into UK in accordance with all applicable laws and guidelines (e.g. EU Guidance on GMP Part 1, Annex 16).
Act as key point of contact with non-EU / UK based GSK manufacturing sites (and with GSK external supply quality and GMP audit teams) for products manufactured outside the EU / UK to ensure QP certification requirements are maintained.
Act as a key point of contact with R&D for new products being imported into EU / UK ensuring a testing location is identified and resourced (as required) and QP certification and release activities meet programme timelines.
Location - Please note: The role can be based at any GSK site in the UK (eg; GSK’s Head-office in London, Barnard Castle, Ware, Worthing, Irvine, Montrose, etc) but please note that there is a requirement to travel to Barnard Castle (County Durham) to review and approve batch-release (as the need arises). It is anticipated that this will be circa 3 to 4 times a quarter.
About You:
You will be a qualified QP (Qualified Person) who has sound knowledge of global, regional and national regulatory requirements and GMP guidelines (including risk management). Knowledge/experience relating to Brexit would be advantageous. You should be comfortable dealing with issues which may initially appear ambiguous or unclear and demonstrate an ability and willingness to help resolve complex problems as they arise. You will be resilient and calm under pressure with strong people skills. You will also have a strong continuous improvement mindset.
CLOSING DATE for applications: Friday 5th of July 2024 (COB)
Basic Qualifications
Qualified Person (QP) qualification.
Relevant experience (eg; knowledge/experience of batch-release and Brexit-related process and guidelines).
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.
