QA Officer Research and Development
We are recruiting for the role of R&D Quality Assurance Officer to support the R&D Quality Assurance Team. The new R&D Manufacturing facility will include sterile and non-sterile manufacturing. As a result Quality Assurance support for new equipment qualification, vendor qualification and new product development from conception through to commercialization will be required.
- To support the Head of Quality and the R&D Quality Assurance Team Lead with the quality assurance function.
- Support R&D with QA support including but not limited to the following:
- batch documentation review
- Assessment of manufacturing events from a QA perspective.
- Electronic Documentation Management System - QUMAS
- Check own work and that of others for accuracy before / prior to 'QA Authorisation' of documentation.
- QA reviewer of Process Compliance Change Controls
- Progress Process Compliance actions and attach evidence as required.
- Perform internal audits as scheduled.
- Review and approval of Regulatory deficiency responses.
- To ensure that all work carried out in compliance with the required standards conforming to company, cGxP, SOPs, regulatory regulations and guidelines, safety and environmental guidelines.
- Report any safety or compliance issues as per company procedures.
- Attend Product review meetings and provide support on the development of new Products
- Liaise with regulatory affairs/ formulations / laboratory personnel to ensure regulatory and quality requirements are met.
- Assist with review of Submission Documentation in support of license applications and customer requirements.
- Noncompliance reporting and corrective action / continuous improvement implementation.
- Support the on-going OOS/IR/CACI closeout programme.
- Complete any assigned actions in the agreed time frame.
- Investigate any incident assigned in a timely fashion.
- Review deviation investigations and actions as required.
- To identify and make recommendations for improvements as part of a team within or outside the department in order to ensure continuous improvement.
- To support on-going projects with respect to the following:
- Vendor review and approval
- Implement safety requirements as per site documentation including SOPs, Safety Statement and COPs
Minimum Qualifications & Experience
- 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 experiences would be of benefit
For more information on this role please contact Darragh on 01-6455250 or firstname.lastname@example.org