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Lead Auditor

Ref: 76150

  • 50,000-65,000
  • 19 Jan 2022
  • Waterford
  • Permanent

Lead Auditor

About the Company

This is a fantastic opportunity to join a leading Pharmaceutical manufacturing site in Waterford. This site has seem massive levels of investment in recent years and much diversification in the product categories manufactured there.
This is an initial 23 month contract role.

About the Position

In this role you will be involved in auditing site GMP activities and suppliers to ensure compliance to GMP requirements, registered product details and applicable local regulations. You will also train and mentor existing auditing staff and SME’s and proactively work with stakeholders to ensure system updates resulting from audit citations reflect regulatory compliance requirements.

Key Responsibilities

  • Perform all activities in compliance with GxP documentation requirements
  • Conduct Site Internal Audits and Supplier Audits ensuring alignment with regulations, global documents and site documents
  • Maintain the in-house audit training programme to reflect regulatory and other changes
  • Issuing comprehensive reports to auditees in agreed timeframes
  • Ensuring suitable holistic action plans are in place to address audit trends and that where necessary non compliances are logged on the site risk register
  • Following up with auditees on any citations given to ensure suitable actions plans are in place
  • Supporting site preparations for external (Agency, customer and corporate) audits and supporting these audits as assigned
  • Supporting responses to citations from external audits as requested
  • Training and mentoring existing auditing staff and SME’s
  • Site representative on global audit response team ensuring issues reported are reviewed for possible impact and appropriately addressed
  • Reporting assigned metrics and trends to various site forums as requested
  • Supporting the site cGMP induction and refresher programmes by supplying content based on audit trends and non-compliances
  • Supporting development of QS Specialist audit responsibilities

Experience/Requirements

  • Degree/Diploma in Science, Pharmacy, Production, Engineering, or related discipline is essential
  • Lead auditor qualification
  • Relevant experience working (3+years) in a Pharmaceutical or Biotechnology industry conducting external and internal audits.
  • First hand experience of supporting regulatory agency and customer audits
  • Hands-on risk management experience

Remuneration Package

An attractive salary and package is on offer including healthcare, pension, bonus and more.
Contact

For more information on the role or any other Engineering or Life Sciences roles call Nigel on 087 3618142 or email me or click the apply button below.


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