Senior Associate QA

An opportunity has arisen for a Senior QA Advisor to join the Clinical Supply Chain Quality Assurance Operations group within Research and Development. The role is based at Harlow, UK but also supporting other sites that fall within the department's responsibilities (e.g. Ware).

The successful candidate will have a critical role in ensuring quality and compliance of Investigational Medicinal Products used worldwide. In addition, the job holder will have the opportunity to further develop existing expertise and to gain experience within an R&D environment.

It is a fantastic role that offers a wide range of development and progression opportunities depending on your passion.,

• Review and recommend release of documentation for a range of dosage form batches and finished clinical trial packs of Investigational Medicinal Products in accordance with GMP/GSK requirements.


• Assessment of Quality QMS Records (e.g. Deviations and third party or internal complaints), make recommendations for corrective and preventative actions and to follow up on the implementation of those recommendations.


• Review and Approve GMP documentation, which may include Standard Operating Procedures, Change Controls and other controlled documents from business partner areas such as Clinical Supply Chain packaging operations and logistics


• Provide advice and support to business partner areas relating to quality matters and process improvement.


• 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, 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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• Experience of QA review of GMP Manufacturing and/or Packaging Documentation of a range of pharmaceutical dosage forms including sterile products and/or review and approval of GMP documentation within a Quality Assurance role


• Proven experience of knowledge of GMP principles and being a decision maker using this knowledge


• Experience working in high pressure environments where there are likely to be conflicting priorities


Preferred Qualifications & Skills:

Please note the following skills are not necessary, just preferred, if you do not have them, please still apply:

• Knowledge of the R&D process, particularly with respect to clinical trials manufacturing and packaging.


• Strong attention to detail


• Good communication skills with the ability to build relationships and trust; and make decisions based on GMP principles


• Previous involvement in Quality Deviations, Third party/Internal Complaints, Change Controls and inspections/audits
  
  At GSK, we have bold ambitions for patients, aiming to positively impact the health of 2.5 billion people over the next 10 years. R&D is committed to discovering and delivering transformational vaccines and medicines to prevent and change the course of disease. Science and technology are coming together in a way they never have before, and we have strong tech-enabled capabilities that allow us to build a deeper understanding of the patient, human biology and disease mechanisms, and transform medical discovery. We are revolutionising the way we do R&D. We're uniting science, technology and talent to get ahead of disease together.


Find out more:

Our approach to R&D.

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.

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