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Quality Assurance Specialist

2 months ago

Worthing, West Sussex, United Kingdom 1054 GlaxoSmithKline Services Unlimited Full time
Job Summary

We are seeking a highly skilled and experienced Quality Assurance Specialist to join our team at GSK Worthing. As a key member of our Quality Assurance team, you will be responsible for ensuring the stability of our products and ensuring compliance with regulatory requirements.

Key Responsibilities
  • Drive the stability process, ensuring procedures meet process requirements.
  • Assist in identifying batches for stability testing, including the need for stability testing following change control or process deviations and to facilitate their sampling.
  • Manage stability storage, labelling and overall stability management of product in chambers.
  • Provide an efficient and accurate sample and stability chamber management service to customers within the GSK network according to ICH, regulatory and capacity requirements.
  • Oversee the planning and strategic management of Stability trials and Stability testing in conjunction with the Value Streams and laboratories at GSK Worthing.
  • Report Stability results in a timely and accurate manner and oversee the Stability Annual Review process.
Requirements
  • Bachelor's degree in a relevant subject or equivalent experience in a role that demonstrates technical understanding of equipment and processes.
  • Strong experience within a Stability related job role.
  • Evidence of report writing skills.
  • Knowledge of global stability regulations.
  • Extensive experience in the use of appropriate software (eg Statistica) for the interpretation of stability data and trends.
Preferred Qualifications
  • Working knowledge of relevant Site systems, e.g. LES, SAP, VQMS.
About GSK

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.

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.