Job Description
SUMMARY Planet Pharma has partnered with a globally recognized Pharmaceutical company who are seeking a Process Quality Excellence Specialist on an 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 require a focus on Good Clinical Practice (GCP), Good Laboratory Practices (GLP), and Pharmacovigilance (PV) regulations and guidance. Looking for mid-level clinical quality professional with 4-6 years of previous experience within clinical quality and a strong GCP background. UCB only wants 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 - the person will be supporting 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, and checking if any new training is necessary or applicable to certain teams. GAP analysis lead - looking at new regulations and how they may affect current SOPs, and 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. TO APPLY Please click ‘apply’ or contact Treasa Recruiter at Planet Pharma for more information: E: talterskye@planet-pharma.co.uk
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SUMMARY Planet Pharma has partnered with a globally recognized Pharmaceutical company who are seeking a Process Quality Excellence Specialist on an 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 require a focus on Good Clinical Practice (GCP), Good Laboratory Practices (GLP), and Pharmacovigilance (PV) regulations and guidance. Looking for mid-level clinical quality professional with 4-6 years of previous experience within clinical quality and a strong GCP background. UCB only wants 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 - the person will be supporting 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, and checking if any new training is necessary or applicable to certain teams. GAP analysis lead - looking at new regulations and how they may affect current SOPs, and 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. TO APPLY Please click ‘apply’ or contact Treasa Recruiter at Planet Pharma for more information: E: talterskye@planet-pharma.co.uk
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