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PV Auditor, Quality Assurance Lead


Senior PV Auditor, QA LeadSuitable Locations: London, Hertfordshire, BedfordshireSalary: Circa 80,000 + Benefits A global generics company is actively recruiting for an experienced Senior PV Auditor, Quality Assurance Lead, to join their expanding business on a permanent basis. As an experienced PV Auditor, you will be required to perform PV related audits globally in relation to all PV activities e.g. system audits, licensing partners and other service providers. You will have substantial experience in the Pharmacovigilance environment, PV auditing and QA processes along with in-depth knowledge of PV regulations and their application globally. Responsibilities: - Work towards timelines, company and personal objectives set by Head of Clinical & PV Quality Assurance - Prepare and lead/support the conduct of PV audits and regulatory inspections - Co-ordinate and document PV audits of processes, systems, projects, sites, including vendors and safety reporting practices according to SOPs and guidelines- Ensure appropriate follow-up of audit findings/Quality issues that may arise - Review, write and approve audit reports and CAPAs issued by internal and external providers- Ensure the Quality Assurance database and any other QA related trackers are maintained and up-to-date to reflect the status of scheduled audits Experience Required; - Experience of managing GVP regulatory authority inspections, including hosting the inspection, preparation of inspection responses, CAPA tracking and follow-up. - Experience of providing QA support for GCP regulatory authority inspections for the PV aspects. - Management of vendors from Quality perspective- Expertise in risk based quality oversight of PV- Ability to manage internal and external auditors conducting audits on a global basis- Ability to work in a multicultural, international environment and be prepared to travel toglobal affiliate offices when safe to do so- A motivated self-starter, with strong influencing skills and negotiating capability The successful applicant will be rewarded with a competitive salary, benefits and flexible working environment. You will work within a truly global company any your role will be pivotal in defining PV and QA processes for the business. If this role is of interest, please get in touch by calling George on 0118 959 4990 or email your cv to [email protected] Already uploaded your CV? Sign in to apply instantly Apply First name Required Last name Required Email address Required Upload your CV Required Upload from your computer Or import from cloud storage Your CV must be a .doc, .pdf, .docx, .rtf, and no bigger than 1MB Your covering message for Senior PV Auditor, QA Lead 4000 characters left Add my CV to PharmiWeb's CV database, and let the jobs come to me! Email me jobs like this one when they become available Please email me a free CV review from Marketing Communication We'd love to send you information about Jobs and Services from by email. Yes please. I'd like to receive emails about jobs and services from I'd like to receive emails from third parties All emails will contain a link in the footer to enable you to unsubscribe at any time. When you apply for a job we will send your application to the named recruiter, who may contact you. By applying for a job listed on you agree to our terms and conditions and privacy policy. You should never be required to provide bank account details. If you are, please email us . is Europe’s leading industry-sponsored portal for the Pharmaceutical sector, providing the latest jobs, news, features and events listings. The information provided on is designed to support, not replace, the relationship that exists between a patient/site visitor and his/her physician.

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Hertford, Bayford, England, Hertfordshire, SG13, United Kingdom

  • Ad ID:  16534908
  • Ad Type:  Offered
  • Posted on:  03/11/2020, 03:00
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