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| Company |  Bond Personnel |
| Record Number |
13585 |
| Job ID | 00020863 |
| Salary |
dependent on experience |
| Preamble |
My Galway based client has a 12 month contract for a Compliance Quality Engineer: |
Job description |
My Galway based client has a 12 month contract for a Compliance Quality Engineer:
Duties & Responsibilities:
Lead & participate actively in the internal audits conducted per audit schedule.
Maintenance of audit schedule.
Preparation of audit reports, audit findings to be reviewed and approved by management.
Support relevant areas in preparation of response plans to audit findings-both internal and external.
Inputting audit responses on the electronic Audit System.
Drive preparations for hosting of external audits.
Drive on time closure of audit actions through use of electronic reporting systems and consistent communication with relevant personnel and their one-over-managers/supervisors.
Participate in audit council conferences and communication of relevant issues to personnel.
Generation and approval of change requests
Provide support to Quality Systems re system/process improvements.
Prepare weekly reports for inclusion in weekly senior site reports.
Verification of checklist for adherence to Part 11 for software applications.
Data integrity audits for submissions.
Qualifications & Experience:
A third level degree in a relevant area such as Science, Engineering or equivalent is essential. (Further postgraduate study in Quality related disciplines would be of benefit).
Understanding, and preferably, training in the relevant Regulations e.g 21 CFRs Part 820, 210/211, ISO 13485:2003, MDD & AIMD essential.
Previous auditing experience, preferably as a Lead Auditor, essential.
Certification to recognized Lead Assessor qualification essential.
Excellent Verbal and written communication skills are essential for this role, together with an ability to be self directed and to effectively interface with various levels and functions across the organization.
Salary dependent on experience
To take advantage of this opportunity call Tanya on (090)6493882 or email your cv
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It is Essential
that the candidate has experience in the following:
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| Essential experience |
Experience required |
| Regulatory Compliance |
2-4 years |
| | Business-level conversational fluency in the following languages is required | English | | Candidate application threshold | 60% |
| Commuter area(s)
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Galway city
Galway county (outside Galway city)
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| Job type(s) | Manufacturing, Purchasing and Logistics
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Compliance Quality Engineer (Contract)