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Senior Analytical Chemist job in Limerick
I am currently recruiting for a Senior Analytical Chemist to join a leading medical device company based in Limerick. My client are the leaders in innovation and strive to make a difference in the medical and healthcare field every day. The Senior Analytical Chemist will be a part of the R&D team and will work on the development of innovative and high quality medical devices.
The primary role of the Analytical Chemist will be to provide analytical input, guidance and support for test method development and validation for test methods required for regulatory submission and or process qualification. The role is expected to analytically and technically support R&D and process development requirements, performing data analysis, interpret results, make actionable recommendations that support QA/RA decision making process and effectively communicate methodologies used. The ideal candidate will come from a test method development and validation background with experience in biomaterial analysis. They will have strong planning skills and will provide guidance to the R&D test team.
- To participate in the planning and running of DOE's, test plans, test method development brainstorming and problem solving sessions.
- To plan, co-ordinate and actively participate in the development and validation of test methods as required for design QA/RA. This will include internal and external testing, biomechanical and chemical analysis test methods. It will require a high standard of investigational and learning activity. It will also involve maintaining records in compliance with regulatory requirements. This will also involve providing guidance to other team members.
- To plan, co-ordinate and actively participate in test equipment qualification.
- To analyse raw materials, sub-components and finished goods associated with the R&D projects and process development. This will involve maintaining clear, precise GLP test records and will require trending, analysis and interpretation of data, and compiling of associated technical reports.
- To maintain appropriate laboratory supplies and equipment to ensure efficient operation of the Laboratories.
- Identify resource requirements for R&D projects and to support and actively participate in the development of the R&D capabilities on site.
- Perform training and method transfer from R&D to the QC team.
- To support QA/RA in investigational work or in regulatory requirements for current products.
- Minimum Degree in Life Sciences or related discipline
- Minimum of 3 years' experience post Degree or 2 years' experience post Masters in test method development, validation as per the ICH guidelines, result interpretation, trouble shooting and equipment qualification.
- Experience in FDA regulated Pharmaceutical or Medical Device Industry with knowledge of QSR (21 CFR Part 820), GLP and MDD
- Good working knowledge of MS Word/Excel/Outlook.
- Experience in gap analysis review of test method/equipment qualifications and/or regulatory standards would be desirable.
- Be a positive, energetic team player, and an advocate for product excellence and quality.
- Proven to be self-directed, self-motivated and able to prioritize and resolve competing priorities.
- Excellent interpersonal and communication skills
- Experience in leadership or guidance roles would be desirable.
- Experience with ISO 10993 would be desirable
- Should enjoy working in a dynamic and results motivated team environment.
- A working knowledge of statistical techniques and analysis would be desirable.
- A working knowledge of planning tools would be desirable.
- Proven experience in the principles and practice of mechanical testing, surface science testing and GC/LC/MS.
If you're free for a quick chat to find out more about my client and their Senior Analytical Chemist job in Limerick, please contact me on 086 839 5533. If you're not free during the day, send me a text and we can arrange a call at later time.
I look forward to hearing from you ? Cliona O'Malley, Senior Recruitment Consultant, email@example.com
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