GVP Auditor - Princeton, United States - Pharmalearner

Description

The GPV Auditor will lead and perform audits with a focus on Pharmacovigilance activities.

Additional tasks are required to support the continuous improvement of the Otsuka Quality System, inspection management, regulatory intelligence activities, SOP and WP management, validation activities, and project liaison activities.

Significant travel in excess of 50% is expectedPharmacovigilance AuditsImplement & maintain the global pharmacovigilance risk-based strategy for audit and risk assessment activitiesLead, plan, conduct, and support internal and external GxP audits in line with the global audit plan, Otsukas business model and applicable proceduresFollow-up on the development, implementation and completion of corrective and preventive actions with internal and external auditeesMaintain a tracking tool for audits, findings and corrective and preventive actionsProvide business support as Global Quality representative for routine software/infrastructure lifecycle activities (systems introduction/maintenance/ retirement)

Ensure continuous improvement and enhancement of the Quality System by supporting global metrics generation and lessons learned from audit/ inspectionCover GxP related Functional Areas, specifically related to GCP, GVP, GMP and CSV.Collaborate with the respective Functional Area Heads/representatives and Global and Regional Quality Leads and functions.

Ensure the establishment and maintenance of the required Quality DocumentationEnsure SOPs/ WPs are compliant with applicable requirements and regulations and mirror the actual Otsuka company processesIdentify process gaps and deficiencies in the Quality System, liaise and collaborate continuously with other Functional Areas and other partners for resolutionManage planned and unplanned deviations reported by the Functional Areas and support them by resolving the deviations.

Develop and support global compliance training procedures in collaboration with other Otsuka companies and provide training in the area of expertise as assigned.

InspectionsSupport the preparation for GxP inspectionsSupport the responses to Regulatory Authorities and provide input to the corrective and preventive actionsFollow-up on the development, implementation and completion of corrective and preventive actions with the inspected Functional AreasMaintain a tracking tool for inspections, findings and corrective and preventive actionsMaintain an overview over the relevant regulatory requirements and state-of-the-art knowledge of development in the professional regulatory environment to be able to provide guidance for timely adaptation of Otsukas procedures.

Evaluate impact of regulatory changes for the Otsuka Quality SystemEnsure information sharing and action takingEnable Otsuka to maintain the Quality System in an compliant state with a changing regulatory environmentProvide advice and act as project liaisonProvide sound advice and interpretations related to current GxP guidelines and regulations to Senior Management and Otsuka employeesBe accountable for quality-related input in decision making processes with relevance for GxP complianceAct as quality liaison for assigned projectsRequirements:

Degree in natural science or equivalent number of years experienceExperience in Pharmacovigilance auditing (Qualification as an auditor preferred)Several years of clinical/industry/Regulatory Authority or otherwise relevant experience, preferably including Quality Management for Pharmacovigilance or Clinical Development or Computer System ValidationExpert knowledge/experience in relevant regulations and guidance documents, e.g.

, in the area of Pharmacovigilance, Clinical Development, Medical Device, IMP management, Regulatory Affairs and PharmacovigilanceExperience in Monitoring, Quality Assurance and/or Good Clinical PracticesExposure to inspectionsCOMPETENCIESUnderstanding of pharmacovigilance requirementsUnderstanding of audits and CAPA managementUnderstanding of change management processesWell versed with MS Office (advance users in Excel & PowerPoint preferred)Excellent communication skills (written and oral) in EnglishProblem solving and resolution skillsAnalytical and creative thinkingGeneral Comment:


NOTES FROM KEREN:

ROS:
Mijal Chavda (Director, Global Quality Management)

Timeline to Hire:
ASAPDuration: 1 yearLocation: Princeton *Ideally based in Princeton onsite (2 to 3 days per week) but will consider strong remote candidatesReason for Opening: New, workload increase#J-18808-Ljbffr