4 GxP Jobs in the Thames Valley

as indicated in applicable controlled documents, are followed Perform other duties, as assigned by management Minimum Required: 8 years in regulatory environment (experience in GXP roles) Experience & regulatory expertise of industry quality systems/standards Ability to interpret applicable regulations/standards Experience in leading process improvement initiatives Ability to more »

issues. Work in close collaboration with Global Regulatory Leads and subject matter experts to ensure clinical trial deliverables are executed. Support internal and external GxP inspections. Leads project teams effectively to escalate and drive resolution of project issues. Effectively frames complex issues for decision-makers. Supports the Associate Director with more »

audits and contract auditors in line with the global audit plan, business model and applicable procedures · Plan, supervise, conduct, and support internal and external GxP audits · Follow-up on the development, implementation and completion of corrective and preventive actions with internal and external auditees · Maintain a tracking tool for audits … Quality System · Ensure continuous improvement and enhancement of the Quality System by supporting global metrics generation and ‘lessons learned from audit/inspection’ · Cover GxP related Functional Areas, specifically thus related to GCP, GVP, GMP and CSV. · Collaborate with the respective Functional Area Heads/representatives · Collaborate with the respective … training procedures in collaboration with other business companies and provide training in the area of expertise as assigned. 3. Inspections · Support the preparation for GxP inspections · Support the responses to Regulatory Authorities · Supervise and provide input to the corrective and preventive actions · Follow-up on the development, implementation and completion more »

in alignment with business objectives.Delivery of medium and large site Capital Projects within budget and timelineManagement of project execution resources and vendorsDeliver projects with GxP and Cybersecurity complianceOversee the coordination and management of project execution resources, including internal teams and external vendorsMaintain continuous engagement with all project stakeholders through regular … updates and strategic meetings to ensure alignment and address concernsJob Requirements:Experience in project management within the pharmaceutical or related industry, particularly with GxP complianceProven capability in managing both IT and OT domainsAbility to understand complex applications and OT asset landscapeIn-depth knowledge of Data Integrity, BMS, EMS, and SCADA more »