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AX-7276 Senior GxP Quality Auditor

AXESS Ltd Published: 1st August 2019
Location
Berkshire, United Kingdom
Job Type

Description

Ref: AX-7276

 

JOB SUMMARY:

As a Global GxP Quality Auditor you’ll be responsible for managing global GMP/GDP audits to ensure GxP compliance of systems, manufacturing processes and vendors, and ensuring the delivery of annual audit programs.

 

BACKGROUND

Global specialty-driven biotechnology group

Offer products in oncology and endocrinology amongst others

Strong pipeline

Launches anticipated over the next 2 years

Will involve circa 60% travel

 

PRIMARY DUTIES

  • As a member of the Global Quality Audit team, the incumbent must ensure that audits are planned, conducted, followed up and managed in accordance with GQA and company procedures as part of a Quality Management System that allows the company to achieve a high standard of compliance with regulatory guidance
  • Responsible for maintenance of the Global Quality audit schedule for audits within scope of this GxP role to ensure completion and adherence to the schedule.
  • Responsible for independently leading, planning, conducting and reporting of routine audits in accordance with the approved schedule.
  • Responsible for review and approval of CAPA plans and in collaboration with stakeholder’s review progress and advises and support the sites in devising and executing remediation actions to ensure compliance to regulatory and Global Quality expectations and requirements.
  • Collaborate with the team to design and enhance the quality management system, including the ongoing development of SOPs, audit supporting tools, checklists, guides and reports.
  • Advise, guide and support sites in the overall regulatory inspection management (preapproval inspections, general GxP inspections) covering inspection preparations, execution of regulatory inspections, preparation of responses to health authorities and inspection follow-up as well as for key customer audits.

 

QUALIFICATIONS / EXPERIENCE REQUIRED:

  • A minimum of a bachelor’s degree is required
  • Significant experience in conducting global pharmaceutical GMP and GDP audits with experience in Regulatory inspections management
  • IRCA qualified
  • Experience in auditing sterile manufacture
  • Demonstrable in-depth knowledge of GPV requirements and regulations
  • Willingness to travel up to 60%

 

BENEFITS:

Corporate

 

TO APPLY:

For a confidential discussion please telephone Sukhveer Gill at AXESS Limited on 020 8560 2300 quoting reference 7276.

To apply, please click the APPLY ONLINE button.

 

KEYWORDS:

GxP, , good manufacturing practice, good distribution practice, GMP, GDP, Quality Assurance, CAPA, Audit, audit manager,  risk evaluation, risk management,, QMS, quality audit, global quality audit, Quality management, Compliance, quality assurance, Manager QA, manager Quality assurance, Global Quality Assurance,  senior manager Global Quality Assurance,   quality assurance, QA,GMP, Quality Systems, global QA, Global Quality Assurance, Senior manager QA, senior manager global QA, audits, critical deviations, change control, risk assessment,  root cause analysis, quality compliance, investigator audit, CMO management

 

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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