Freelance GCP Auditing specilaist, Remote UK, 1 Year + Assignment
Focus Life Sciences is a Leader both on a permanent and contract basis and is the preferred choice for many consulting companies and end users on a global basis.
My client are a specialsist Neurology/Oncology company who are a market leader in the field of Rare Diseases, the comoany are in need of a specilaist in coordination and planning for GCP Audits for UK and German sites.
Key assignment Goals:
· Supporting oversight management of the audits of GCP-related nature for internal processes and systems
· Supporting ESP onboarding and qualification activities.
· Support internal GCP compliance excellence through Deviations and CAPA management and support the Global Inspection Management Office (GIMO) and the GCP Inspection Lead to prepare for GCP Inspection Readiness.
· To support the Data Integrity office in the GCP area
· Support the management of the Global Audit Program and coordination activities in EU in close collaboration with the Global Audit Coordination Committee (GACC) and it’s Lead.
· Contribute to the implementation of a risk based GCP vendor audit program and provides oversight / management in scheduling these audits via thorough risk assessment.
· Support to all FAs in clinical compliance issues such as deviations and non-conformities arise. Additionally, provides consultation for the implementation of proper CAPA to resolve deviations and non-conformities.
· Support the conduct of remote and onsite GCP audits in EU as co-auditor in training per international regulatory requirements related to clinical trials, including ICH (International Council for Harmonization) guidance on Good Clinical Practice (GCP), FDA 21 CFRs and industrial best practice.
· Contribute to the various GQM activities of GCP data integrity, software compliance and GCP requirements for audits and internal gap analyses.
· Support as a GQM GCP representative and work with EU Data Security and Privacy team and other FAs in vendor qualification, onboarding, and continued oversight.
· Support the Global Inspection Management Office (GIMO) and the GCP Inspection Lead to prepare for GCP Inspection Readiness.
· Minimum 5 years of experience in managing and coordinating audits in GCP environment.
· High level of understanding of international GCP requirements and standards in the pharmaceutical, medical device and biotech industries.
· Demonstrated knowledge of management and oversight of GCP audits within global health and regulatory authority environment such as FDA, MHRA, EMA and BfARM.
· Solid understanding of global clinical development and robust experience on GCP-ICH, audits and inspections, clinical compliance, QMS principles, GCP/ICH guidelines.
· Auditing certification from reputed organizations such as SQA, ASQ or CQA (Useful to have)
The rate for the position has a range of 550-600 per day.
Qulatity Assurance GCP Coordination Auditing Inspections