Job Description
The CK Group is recruiting for a Process Quality Excellence Specialist to join a global pharmaceutical company on a contract basis, initially for 12 months. This is a hybrid role requiring two times per week on-site work.
* Support the development of quality and compliance infrastructure in GCSO; assist with creating/revising policies, Standard Operating Procedures (SOPs), processes, and best practices as needed.
* Collaborate with Global Quality, Patient Safety, Regulatory Affairs, strategic partners, and other stakeholders to ensure compliance with ICH GCP, GLP, PV and relevant local and international regulations.
* Participate in audit and inspection planning with Global Quality.
* Work with Clinical Project Managers to manage Study Specific Training activities within the Learning Management System (LMS); create and maintain study training matrices, develop curriculums and courses, activate/deactivate study training, and provide support to GCSO stakeholders.
* Represent or ensure GCSO representation and preparation during audits/inspections.
Your Background:
* Strong pharmaceutical experience, preferably in a global Quality Assurance or Clinical Development setting.
* In-depth experience of GCP, including hands-on experience in global GCP audits and/or inspections.
* FDA/EMA inspection readiness experience is essential.
About Us:
Our client is a global biopharmaceutical company focused on creating value for people living with severe diseases in immunology and neurology now and into the future.
Location:
This role is based at our client's site in Slough.