Our client is seeking a Research & Development Data Reviewer to perform technical reviews of all research and development group activities, including analytical & formulation development.
- To review raw data from testing of raw materials/In-Process samples/finished products in a timely & efficient manner.
- 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.
- To review the development and validation of robust, sound analytical methods.
- Complete investigations in a timely and efficient manner where applicable.
- To draft and review test methods, validation protocols and reports.
- To prepare submission documentation in support of license applications.
- To identify and make recommendations for improvements as part of a team within or outside the department in order to ensure continuous improvement.
- To perform additional team tasks as agreed to support effective running of the Business.
- To assist in the preparation for customer/ regulatory inspections.
- To support all other on-going laboratory functions & requirements.
- To assist in the training of new employees.
- To take part in/ lead lab investigations.
- Liaising directly with customers and attending conference calls when required.
- Attending internal project review meetings when required.
- Ensure requirements Safety Statement are implemented.
- Continuously promote a positive safety culture by leading by example.
- Implement safety requirements as per site documentation including SOP's, Safety Statement and COP's.
- Degree in Analytical Chemistry/ Pharmaceutical Science or a related discipline. .
- At least 3 years' experience working in a related technical environment.
- Competent knowledge of analytical methods and lab instrumentation.
- Excellent knowledge of GxP.
- Working knowledge of Empower lab software.
- Excellent technical report writing skills.
- Excellent computer Skills - MS Word, Excel etc.
- Prior experience of electronic document management systems advantageous.
- Project management skills would be an advantage.
- Effective communication skills are essential.
- Problem solving & trouble-shooting skills are essential.
For further information on this role please contact James Kelly on 016455250 or firstname.lastname@example.org