• 14 Danville Business Park, Kilkenny, Ireland
  • +353 56 77 90100
  • info@prochem.ie
  • Quality Auditor – Carlow

    Duties:

     

    • The Quality Auditor conducts routine audits of data, information, procedures, equipment and systems (including computer systems), and/or facilities to ensure the compliance with SOPs and GMPs and worldwide regulations.
    • Review and approve production and analytical documentation accompanying the release of API, Safety Assessment or clinical supply lots (bulk and packaged) to ensure conformance to appropriate regulatory requirements.
    • In addition, the Auditor communicates and resolves audit comments with client areas.
    • Under supervision, or as part of a team, perform audits or inspections of assigned areas or systems to assess compliance with regulatory and Company standards.
    • Issue reports summarizing deficiencies and work with areas to execute remedial action.
    • Notify appropriate management of inspection result.
    • Works with moderate work direction and is skilled and knowledgeable to the position.

     


     

    Education & Qualifications Required:

     

    • Experience should be in the pharmaceutical/chemical industry or government drug-regulatory agency with a working knowledge of cGMP regulations.
    • Effective communications (oral/written) and interpersonal skills are necessary.

     

     

    To Apply

     

    If you would like to discuss this vacancy or to discuss your career and other job opportunities in confidence, contact us:

    14 Danville Business Park, Kilkenny, Ireland
    +353 56 77 90100
    recruitment@prochem.ie

    Click here to submit your CV