GCP Quality Specialist

23 hours ago

London, Greater London, United Kingdom Hyper Recruitment Solutions Full time £40,000 - £80,000 per year

We are currently looking for a GCP Quality Specialist to join a leading pharmaceutical company based in the Berkshire area. As the GCP Quality Specialist, you will be responsible for developing and maintaining clinical quality systems/procedures and ensuring quality and compliance risks are appropriately identified and mitigated.

Key Duties And Responsibilities
Your duties as the Senior Process Quality Excellence Specialist will be varied; however, the key duties and responsibilities are as follows:

  • As the GCP Quality Specialist, you will support the Head of Process Quality Excellence in developing and maintaining clinical quality systems and procedures.
  • As the GCP Quality Specialist, you will collaborate with Global Quality, Patient Safety, Regulatory Affairs, and other stakeholders to ensure compliance with international regulations and inspection readiness.
  • As the GCP Quality Specialist, you will lead GCSO Inspection Readiness Activities and participate in audit and inspection planning.
  • As the GCP Quality Specialist, you will provide guidance and training on Good Clinical Practice (GCP), Good Laboratory Practices (GLP), and Pharmacovigilance (PV) to staff.

Role Requirements
To be successful in your application to this exciting role as the Senior Process Quality Excellence Specialist, we are looking to identify the following on your profile and past history:

  • Relevant degree in a scientific or related field.
  • Proven industry experience in clinical quality and compliance. GCP experience is a must. A Clinical Project Manager with QMS experience (Editing and writing SOPs, Quality site management etc), or an established Quality/QA professional with strong experience in Clinical/GCP would be suitable candidates.
  • A working knowledge and practical experience with GCP, GLP, and PV regulations.

Key Words: Senior Process Quality Excellence Specialist / GCSO / Clinical quality systems / Good Clinical Practice / Good Laboratory Practices / Pharmacovigilance / inspection readiness / Audit planning / compliance policies / CAPA tracking / GCP

Hyper Recruitment Solutions Ltd (HRS) is an Equal Opportunities employer. We welcome applications from anyone who meets the role requirements. HRS exclusively supports the STEM sectors, combining recruitment expertise with scientific knowledge to help you advance your career.

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