Overview

Reference Number: JO-2010-457017
Senior PV Auditor, QA Lead
Rate: £78,000 – 80,000
Job Type: Permanent
Location: Central London / West End

Senior PV Auditor, QA Lead
Suitable Locations: London, Hertfordshire, Bedfordshire
Salary: 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 to
global 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 george@clinicalprofessionals.co.uk

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