-
Pharmacovigilance Auditor
Found in: Ziprecruiter UK C2 - 2 hours ago
Parkside Recruitment Slough, United KingdomJob Description · Senior Manager Global Quality Operations (Senior PV Auditor) · This is a home-based role offering a fantastic package including generous salary, incentive bonus, home based allowance plus much more. My client a Global pharmaceutical company are seeking an experi ...
-
Pharmacovigilance Auditor
Found in: Appcast UK C C2 - 5 days ago
Parkside Recruitment Slough, United KingdomSenior Manager Global Quality Operations (Senior PV Auditor) · This is a home-based role offering a fantastic package including generous salary, incentive bonus, home based allowance plus much more. My client a Global pharmaceutical company are seeking an experienced Senior Manag ...
-
Computer Auditor
Found in: Jooble UK O C2 - 4 days ago
Parkside Recruitment Slough, Berkshire, United KingdomSenior Manager Global Quality Operations (Senior PV Auditor) This is a home-based role offering a fantastic package including generous salary, incentive bonus, home based allowance plus much more. My client a Global pharmaceutical company are seeking an experienced Senior Manager ...
-
Director - Quality Assurance
Found in: Jooble UK O C2 - 2 days ago
Gilead Sciences, Inc. Uxbridge, Greater London, United KingdomDirector - Quality Assurance page is loaded · Director - Quality Assurance · Bewerben locations United Kingdom - Uxbridge posted on Vor mehr als 30 Tagen ausgeschrieben job requisition id R For Current Gilead Employees and Contractors: · Please log onto your Internal Career S ...
-
Senior Director
Found in: Jooble UK O C2 - 3 days ago
Gilead Sciences, Inc. Uxbridge, Greater London, United KingdomDirector - Quality Assurance page is loaded Director - Quality Assurance · Bewerben locations United Kingdom - Uxbridge posted on Vor mehr als 30 Tagen ausgeschrieben job requisition id R For Current Gilead Employees and Contractors: · For more than 35 years, we've tackled dise ...
-
Director - Quality Assurance
Found in: Talent UK C2 - 3 days ago
Gilead Sciences, Inc. Uxbridge, United KingdomDescription · Director - Quality Assurance · Gilead Sciences, Inc. is a biopharmaceutical company that has pursued and achieved breakthroughs in medicine for more than three decades, with the goal of creating a healthier world for all people. The company is committed to advanci ...
-
Associate Director
Found in: Jooble UK O C2 - 3 days ago
Johnson & Johnson High Wycombe, Buckinghamshire, United KingdomAssociate Director, Pharmacovigilance Audit Programme Lead (m/f/d) · Audit Strategy and Auditing: · Providing support and input to shape, transform, and execute RDQ QA PV audit strategies for Marketing Partners and Distributors in order to enhance the effectiveness and sustainab ...
-
Director GVP Quality
Found in: Talent UK C2 - 1 day ago
Kyowa Kirin Marlow, United KingdomOverview · At Kyowa Kirin International (KKI), our purpose is to make people smile. This means more than drug discovery and development; it is about embedding care into everything we do to make a difference every day for those that need it most. We're an inclusive pharmaceutical ...
-
GVP Auditor
Found in: Jooble UK O C2 - 22 hours ago
Qualitas London, United KingdomThis role is remote with travel*** · We are currently searching for a remote GVP auditor to join an international CRO. · The role will be responsible for deliverly of pharmacovigilance services to their clients including glbal pharma and biotech companies. · Responsiblities · Pre ...
-
Contract Compliance Auditor
Found in: Jooble UK O C2 - 1 day ago
ProPharma Group United KingdomFor the past 20 years, ProPharma has improved the health and wellness of patients by providing advice and expertise that empowers biotech, med device, and pharmaceutical organizations of all sizes to confidently advance scientific breakthroughs and introduce new therapies. As the ...
-
Auditor - Technology (Contract)
Found in: Jooble UK O C2 - 22 hours ago
ProPharma Group United KingdomGVP Auditor, Compliance & Quality Assurance (EU/UK) page is loaded GVP Auditor, Compliance & Quality Assurance (EU/UK) · Apply locations Leiden Harlow time type Full time posted on Posted 30+ Days Ago job requisition id JR 358 ProPharma Group is the leading global, independent, s ...
-
GVP Auditor
Found in: Jooble UK O C2 - 1 day ago
ProPharma Group United KingdomFor the past 20 years, ProPharma has improved the health and wellness of patients by providing advice and expertise that empowers biotech, med device, and pharmaceutical organizations of all sizes to confidently advance scientific breakthroughs and introduce new therapies. As the ...
-
GVP Auditor, Compliance
Found in: Jooble UK O C2 - 22 hours ago
ProPharma Group United KingdomGVP Auditor, Compliance & Quality Assurance (EU/UK) page is loaded · GVP Auditor, Compliance & Quality Assurance (EU/UK) · Apply locations Leiden Harlow time type Full time posted on Posted 30+ Days Ago job requisition id JR 358 ProPharma Group is the leading global, independen ...
Pharmacovigilance Auditor - Slough, Berkshire, United Kingdom - Parkside Recruitment
Description
Senior Manager Global Quality Operations (Senior PV Auditor)This is a home-based role offering a fantastic package including generous salary, incentive bonus, home based allowance plus much more.
My client a Global pharmaceutical company are seeking an experienced Senior Manager, Global Quality Operations to manage and perform audits with focus on Pharmacovigilance audits.
Responsibilities include Continuous improvement of the Quality System Pharmacovigilance Audits Inspections - Regulatory Intelligence Provide advice and act as project liaison Skills Degree in natural science or equivalent number of years' experience Experience in Pharmacovigilance auditingKEY RESPONSIBILITIES & DECISIONS1.
Pharmacovigilance Audits· Implement & maintain the global pharmacovigilance risk-based strategy for audit and risk assessment activities· Manage 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, findings and corrective and preventive actions· Select and manage qualified service providers for Global Quality, e.g., contract auditors· Provide business support as Global Quality for routine software/infrastructure lifecycle activities (systems introduction/maintenance/retirement)· 2.
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 Global and Regional Quality Leads and functions· Ensure the establishment and maintenance of the required Quality Documentation· Ensure SOPs/ WPs are compliant with applicable requirements and regulations· Ensure SOPs/ WPs mirror the actual company processes· Identify process gaps and deficiencies in the Quality System, liaise and collaborate continuously with other Functional Areas and other partners for resolution· Manage 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 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 of corrective and preventive actions with the inspected Functional Areas· Maintain a tracking tool for inspections, findings and corrective and preventive actions 4.
Regulatory Intelligence· Maintain 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 procedures.· Evaluate impact of regulatory changes for the Quality System· Ensure information sharing and action taking· Enable to maintain the Quality System in an compliant state with a changing regulatory environment 5.
Provide advice and act as project liaison· Provide sound advice and interpretations related to current GxP guidelines and regulations to Senior Management and employees· Be accountable for quality-related input in decision making processes with relevance for GxP compliance· Act as quality liaison for assigned projectsQUALIFICATIONS/ EXPERIENCE· Degree in natural science or equivalent number of years' experience· Experience 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 Validation· Expert knowledge/experience in relevant regulations and guidance documents, e.g.
, in the area of Pharmacovigilance, Clinical Development, Medical Device, IMP management, Regulatory Affairs and Pharmacovigilance· Experience in Monitoring, Quality Assurance and/or Good Clinical Practices· Exposure to inspections COMPETENCIES· Understanding of pharmacovigilance· Understanding of audits and CAPA management· Understanding of change management processes· Well versed with MS Office (advance users in Excel & PowerPoint preferred)· Excellent communication skills (written and oral) in English· Problem solving and resolution skills· Analytical and creative thinking
