Job Description

CK Group are recruiting for a Senior Process Quality Excellence Specialist to join a global pharmaceutical company, based in Slough on a contract basis initially for 12 months. This is a hybrid role with 2 times a week required on site.

Salary:

£34.75 (PAYE) per hour or £47.31 per hour (Umbrella) 

Senior Process Quality Excellence Specialist Role:

Support the HPQE in GCSO quality and compliance infrastructure development; assist with creation/revision of appropriate quality and compliance policies, Standard Operating Procedures (SOPs), processes, and best practices as needed.

Work in collaboration with Global Quality, Patient Safety, Regulatory Affairs, strategic partners, and other stakeholders to ensure compliance with International Council for Harmonization of Technical Requirements for Pharmaceutical for Human Use (ICH) GCP, GLP, PV and relevant local and international regulations and to ensure inspection readiness.

Lead and drive GCSO Inspection Readiness Activities across all GCSO functions working closely with the relevant inspection team(s).

Provide relevant GCP, GLP, and PV guidance and training to GCSO staff for all phases of clinical drug development.  

In liaison with the Clinical Project Managers, for managing Study Specific Training activities within the Learning Management System (LMS). This includes creating and maintaining study training matrices, developing relevant curriculums and courses, activating and deactivating study training for study team members, and providing support to GCSO stakeholders as needed.

Stay abreast with GCP, GLP, regulatory, and industry trends. Share key information gathered via professional associations and conferences (upcoming regulations, best practices) within the GCSO Practice, Global Regulatory Affairs, and Global Quality.Your Background:

• Strong pharmaceutical experience, preferably in a global Quality Assurance or a Clinical Development setting.

• Experience writing SOPs (essential)

• Experienced with Veeva Systems

• In depth experience of GCP, including hands on, in-depth experience in global GCP audits and/or inspections 

• FDA/EMA inspection readiness experience is essential.

Company:

Our client is a 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.

Apply:

For more information, or to apply for this Senior Process Quality Excellence Specialist role please contact the Key Accounts Team on (phone number removed) or email (url removed). Please quote reference (Apply online only).

It is essential that applicants hold entitlement to work in the UK

Please note:  This role may be subject to a satisfactory basic Disclosure and Barring Service (DBS) check