Quality Auditor

Location
Hertfordshire
Salary
On Application
Posted
19 Nov 2018
Closes
19 Dec 2018
Ref
CWi
Discipline
Quality, QA / QC
Contract Type
Contract

Qualifications:

  • 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. 

Responsibilities: 

  • 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.

 

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