Quality Auditor

Competitive
Contract
Carlow
18 Jul 2019
BBBH736532

The Quality Auditor conducts routine audits of data, information, procedures, equipment and systems

Quality Auditor: Pharmaceuticals: South East

Job Purpose:

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

Key Responsibilities:

  • 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.

Qualifications and Experience:

  • 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.

Morgan McKinley is acting as an Employment Agency in relation to this vacancy.

Please note that any references to salary or pay rates in this advertisement and in the salary refinement section are indicative only and should only be used as a guide.

Similar Jobs

Dublin
Contract
Competitive
Dublin
Permanent
Competitive
Fiona Durkin's picture
Senior Consultant
01 6324650 | fdurkin@morganmckinley.ie