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Employer ICDS Recruitment
Job Title Quality Assurance Officer - R&D

Quality Assurance Officer - R&D: County Waterford.

Job Purpose: To support the R&D Quality Assurance Team Lead, Manager & Head of Quality with the development, implementation and maintenance of the quality standards and systems to ensure that products comply with procedures, specifications and cGMPs.


1. To support the Head of Quality and the R&D Quality Assurance Manager & Team Lead with the quality assurance function.
2. Support R&D with QA support including but not limited to the following:
a. batch documentation review
b. assessment of manufacturing events from a QA perspective.
3. Electronic Documentation Management System - QUMAS
a. Check own work and that of others for accuracy before / prior to ‘QA Authorisation’ of documentation.
b. QA reviewer of Process Compliance Change Controls
c. Progress Process Compliance actions and attach evidence as required.
4. Perform internal audits as scheduled.
5. Review and approval of Regulatory deficiency responses.
6. To ensure that all work carried out is in compliance with the required standards conforming to company, cGxP, SOPs, regulatory regulations and guidelines, safety and environmental guidelines.
7. Report any safety or compliance issues as per procedures.
8. Attend Product review meetings and provide support on the development of new products
9. Liaise with regulatory affairs/ formulations / laboratory personnel to ensure regulatory and quality requirements are met.
10. Assist with review of Submission Documentation in support of license applications and customer requirements.
11. Non-compliance reporting and corrective action / continuous improvement implementation.
12. Operation of SAP (ERP System) Quality function as per procedures.
13. Support the on-going OOS/IR/CACI closeout programme.
a. Complete any assigned actions in the agreed time frame.
b. Investigate any incident assigned in a timely fashion.
c. Review deviation investigations and actions as required.
14. To identify and make recommendations for improvements as part of a team within or outside the department in order to ensure continuous improvement.
15. Health & Safety
a. Implement safety requirements as per site documentation including SOPs, Safety Statement and COPs
b. Report any hazards

Minimum Qualifications & Experience sought:

BSc (Require Quality Management as a part of degree)
Minimum of 2 - 4 years' QA experience in a GMP compliant role
Experience with desktop and internet-based software applications (e.g. electronic document management system, MRP system) an advantage but not essential.
Excellent communication and presentation skills
Focus on quality and detail
Careful planning to achieve accurate and timely results
Ability to define and manage own tasks and schedules
Experience performing and assessing risk/impact assessment an advantage
Sterile manufacturing experience would be of benefit

This job originally appeared on
Location Waterford
Date Added 67 days ago
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