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Validation Compliance Specialist

Employer
Manpower Ireland
Location
Carlow
Salary
Negotiable
Closing date
3 Nov 2017
Responsibilities:
*The Quality Auditor / Automation Compliance Specialist 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.

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.

For more information contact justin.pankinas@manpower.ie

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