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AX-7185 GxP Audit Manager – PV

AXESS Ltd Published: 8th January 2019
Location
South East, United Kingdom
Job Type

Description

Ref: AX-7185

 

JOB SUMMARY

Play a key role in driving compliance culture through this unique opportunity to further develop your PV Audit experience within a global QA division and at the HQ of a global specialty pharmaceutical organisation.  This is an opportunity to provide real QA leadership and oversight across a broad range of safety systems and processes.

 

BACKGROUND

Global Pharmaceutical Company

Global Headquarters / Global Remit

National and international travel involved to audit partner organisations

Reporting to Senior Manager PV QA

 

PRIMARY DUTIES

The main focus of the GxP Audit Manager - PV is to provide quality oversight for pharmacovigilance and device vigilance audit activities, including setting up and maintaining a risk based audit strategy.

Additional responsibilities and tasks:

  • Oversee and provide feedback to PV auditors to discuss findings, emerging risks and identify actions to address identified risks, ensuring formal feedback is provided to senior management on a regular basis
  • Participate in the development and implementation of systems and processes required to support global audit processes and quality assurance requirements.
  • Participate in and support PV client audits, PV Regulatory inspections and device vigilance aspects of notified body audits on behalf of all the company’s legal entities.
  • Plan and conduct PV audits of affiliates, vendors, partners and systems in line with the PV audit strategy
  • Serves as a PV QA expert within the business, proving advice and guidance to the organisation and its partners.

 

QUALIFICATIONS / EXPERIENCE REQUIRED:

A life science degree is an essential pre-requisite.

Current experience of quality assurance, a couple of years in which should be focused on pharmacovigilance compliance and auditing.

Proven experience in over-sight of Pharmacovigilance QA activities for commercial marketed products

Experience supporting partner audits and competent authority PV inspections

Strong analytical skills with highly developed quality system knowledge

Excellent influencing skills and ability to establish effective working relationships with personnel at all levels internally and within third parties

Proven experience in auditing a wide range of GVP processes and suppliers

Medical Device Vigilance experience is desirable

Before you apply for this position it is vital that you are in possession of an EU or UK passport or relevant visa to work without restrictions in the UK.

 

BENEFITS:

Competitive

 

TO APPLY:

For a confidential discussion please telephone Christian Simon at AXESS Limited on 020 8560 2300.

To apply, please click the APPLY ONLINE button.

 

KEYWORDS:

PV Auditor / GPV Auditor /  GPV Audit Manager / GPV Audit Lead / PV QA Manager / PV Manager / QA PV Manager / PV Audit roles / PV Manager Auditing / PV AUDIT MANAGER / LONDON / London / South East / Berkshire / Bucks / Oxfordshire / Hertfordshire / Herts / Middlesex/ Maidenhead / Uxbridge / Marlow / Harrow / GPvP / GVP / CAPA / Drug Safety Auditor / Pharmacovigilance Compliance / Inspections / GXP audit

 

ABOUT AXESS:

AXESS has been operating since 1990

We are a recruitment business dedicated to the pharmaceutical industry, specialising in Medical Affairs, Regulatory Affairs & Clinical Development

We match professional candidates to the best permanent, contract and interim roles in the market.

 

 

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