SUMMARY
Planet Pharma has partnered with a globally recognized Pharmaceutical company who are seeking a Process Quality Excellence Specialist on a initial 12 month contract.
RESPONSIBILITIES
The Process Quality Excellence Specialist (PQES) will support the Process Quality Excellence Lead (PQEL) for GCSO in developing and maintaining its clinical quality systems/procedures and ensuring quality and compliance risks are appropriately identified and mitigated. Activities include all aspects of clinical studies that are managed by GCSO and requires a focus on Good Clinical Practice (GCP), Good Laboratory Practices (GLP), and Pharmacovigilance (PV) regulations and guidance.
* Looking for mid level clinical quality professional, 4-6 years previous experience within clinical quality with strong GCP background
* Want to see profiles of candidates with GCP Clinical Trial or GCP audit and inspection experience. They do not want to see GMP/GLP background.
* Focused on writing SOPs and managing training assignments - person will be supporting with the management of the quality and compliance processes training for the GCSO (Global Clinical Sciences and Operations) group - ensuring training matrices for each role are up to date, checking if any new training is necessary or applicable to certain teams etc.
* GAP analysis lead - looking at new regulations and how they may affect current SOPs / creating SOP revisions based on gaps identified.
* Not responsible for audits and inspections as this is the focus of another team member - may be involved in answering a finding or assisting with prep.
* Systems: Veeva Vault and Veeva TMF - experience with these would be a plus
LOCATION
Slough
We are an equal opportunities Recruitment Business and Agency. We welcome applications from all suitably qualified candidates regardless of their race, sex, disability, religion/belief, sexual orientation or age.
www.planet-pharma.com
TO APPLY
Please click ‘apply’ or contact Trae Cook-Appiah - Recruiter at Planet Pharma for more information: