Qualified Person

4 weeks ago


Harlow, Essex, United Kingdom GSK Full time
About the Role:

We are seeking a highly skilled Qualified Person to join our Quality Assurance team at GSK. As a Qualified Person, you will be responsible for performing quality assurance activities and providing quality oversight of GMP functions within our Pharmaceutical Research & Development processes.

Key Responsibilities:
  • Provide Qualified Person certification and perform QP release of bulk and primary packed Investigational medicinal products.
  • Ensure compliant operations are in place for UK certification of batches of Investigational Medicinal Products and assure products meet regulatory requirements.
  • Maintain knowledge of legislation changes applicable to QP Certification and propose mitigation for compliant management.
  • Provide QP advice to GSK project teams and external collaboration partners concerning acquisitions and unlicensed medicines.
  • Build and maintain internal and External business relationships and provide oversight of manufacturing facilities.
  • Participate in audits/investigations and recommend corrective and preventative actions.

About You:

We are looking for a self-motivated Qualified Person with strong experience of working in quality at a sophisticated manufacturing site. You will be resilient and calm, with strong communication skills and the ability to work effectively in a team environment.

About GSK:

GSK is a global biopharma company with a special purpose – to unite science, technology and talent to get ahead of disease together. 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).
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