Quality Assurance Research and Design Officer
Our Client in the County Down area have a requirement for a Quality assurance R&D Officer reporting to the QA Manager, the role’s primary responsibility would be to review QA documents in the process of new product development. For more information please contact Adam Cromwell or see our website.
Attractive Salary and Benefits Package
- Auditing and reporting of findings of R&D and Control Phase documentation including but not limited to
- Pre-approval and post approval stability documentation including analytical data and certificates of analysis
- MDV protocols and reports and analytical data
- NPPV protocols, method Transfer Protocols and data
- Technical PV protocols and reports
- MOAs and Report Books o CMC section of new product registrations
- Review of documentation prior to commencement of full scale commercial production
- Issuance of protocols and reports to MDV and NPPV R&D, as required
- Liaise with TT teams, Change Control teams, TT leads and R&D Project Managers, as required
- Maintain an awareness of current national and international regulations and requirement s for GMP and other relevant quality standards and advising on the requirements
- A relevant third level qualification or have at least 2 years’ experience in a GMP or GLP environment
- Knowledge/experience in Quality Control Analytical Techniques
- Proven ability to organise, plan and prioritize multiple concurrent tasks whilst maintaining a high level of accuracy in all work produced along with a proven ability to meet deadlines.
- Have excellent interpersonal and communication skills.
- Work well within a team and on own
- Experience with compliance software including but not limited to raising deviations and CAPA’s
- Experience with Microsoft Office (including Excel and Word)
- The ability to read/interpret Laboratory procedures, methods and data.
- Awareness of current national and international GMP regulations
For further information, and to apply for this Quality Assurance R&D Officer position or other engineering opportunities, please contact Adam Cromwell or visit our Website.
Expert, confidential recruitment advice
Salary is usually negotiable, salary details listed are to be used as a guide and are based on factors such as your experience and expertise.
We reserve the right to heighten short listing criteria dependent upon the calibre of response.