Quality Assurance Specialist

We have an excellent new opportunity for Quality Assurance Specialist with multinational medical devices client based in Limerick city. Position will report to Quality Manager, will be offered on

initial 9 month contract with significant opportunity to extend for the right candidate.

Job Summary:                       Responsible for Batch Record Review, Product Release and Document Control Management

Job Duties and Responsibilities:

1. Batch Record Review:

• Review manufacturing batch records for compliance to quality requirements and product specifications prior to release.
• Ensure outstanding issues/errors uncovered during the review process are resolved effectively, accurately and in a timely manner.
• Manage and maintain batch record storage area and batch record archive.

2. Product Release:

• Issue Certificates of Compliance and Analysis.
• Execute product release activities.

3. Document Control:

• Coordinate the introduction and approval of new and revised documents.
• Management and control of obsolete and inactive documentation.
• Management and maintenance of document storage areas and document archives.

4. Supplier Approval:

• File certification required for supplier approval.

5. Other Duties:

• Makes identifiable and substantial contributions to continuous improvement. Performs all duties consistent with established company guidelines consistent with ISO 9001, 13485, 14001 & 45001 and those elements of cGMP deemed necessary to support our business (as outlined in the Quality Manual). Actively complies with and endorses Department and Company objectives.
• Assist in the provision of ISO and SOP training.
• Assist in customer/certification audits.

Job Specification:

1. At least 5 years relevant experience, preferably in Quality Assurance within the medical or pharmaceutical industry.
2. In depth knowledge of Microsoft Word, Microsoft Excel and VBA.
3. Enthusiastic, energetic and self motivated.
4. Capable of working on own initiative.
5. Ability to work with cross functional teams.
6. Excellent knowledge of ISO requirements.
7. Excellent interpersonal and communication skills.
8. Strong attention to detail.

To apply for this position, please email your cv to nuala.mcmahon@eflexes.com or call 086 6033772 to discuss in confidence.