Job Overview
We are seeking a Process Quality Excellence Specialist to join our client's team. This role will support the development of quality and compliance infrastructure, including policies, Standard Operating Procedures (SOPs), and best practices.
The successful candidate will have experience in pharmaceutical quality assurance, preferably in a global setting. They will be responsible for ensuring compliance with International Council for Harmonization of Technical Requirements for Pharmaceutical for Human Use (ICH) GCP, GLP, PV, and relevant local regulations.
This is a hybrid role requiring 2 times a week on-site presence at our client's site in Slough. The successful candidate will work collaboratively with Global Quality, Patient Safety, Regulatory Affairs, and other stakeholders to achieve inspection readiness and improve quality processes.
Salary Information
The hourly rate for this role is £20.03 (PAYE) or £27.27 per hour (Umbrella).
Key Responsibilities
This role includes:
* Supporting the development of quality and compliance infrastructure.
* Collaborating with stakeholders to ensure compliance with ICH GCP, GLP, PV, and relevant local regulations.
* Participating in audit and inspection planning.
* Managing Study Specific Training activities within the Learning Management System (LMS).
About Us
Our client is a global biopharmaceutical company focused on creating value for people living with severe diseases in immunology and neurology. This role offers an opportunity to contribute to the company's mission and make a meaningful impact in the industry.
Required Skills and Qualifications
The ideal candidate will have 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, is essential. FDA/EMA inspection readiness experience is also required.