Overview:
An exciting opportunity to become part of a dynamic team responsible for the R&D of IVD products. The team is responsible for a diverse range of activities including analytical development, product development, verification and validation and on-market support.
Responsibilities:
The successful candidate will:
* Perform and plan design verification and analytical validation studies in the laboratory for In Vitro Diagnostics products.
* Develop, test and refine prototype products.
* Generate test protocols, review and analyze results, and generate V&V reports per current applicable technical guidelines and the quality management system requirements.
* Plan day to day activities, ensure sufficient supplies of materials to carry out tasks etc and organise all proficiency testing within the laboratory.
* Carry out work in accordance with defined processes and laboratory procedures.
* Ensure that all work is compliant within the existing quality processes.
* Perform investigative work as required by the organization to support reagent kits
* Maintain detailed experimental records.
* Create and revise laboratory SOPs as required
* Travel to other sites/ countries for the transfer of knowledge etc.
In return you will receive:
* Learning and development opportunities to further your career.
* Competitive salary
* Private health insurance
* Life and long term disability insurance
* Company pension contributions
* EAP program
Qualifications:
* Proven experience of working in a laboratory with analytical equipment such as HPLC or UPLC. Practical experience of LC/MS/MS would be an advantage.
* Ability to operate under a Quality System and knowledge of Good Laboratory Practice (GLP).
* Experience working in an R&D environment (pharmaceutical or medical device) would be advantageous.
* Familiarity with basic laboratory procedures including gravimetric and volumetric preparations.
* Microsoft excel training or substantial experience utilizing excel is required. Ability to use Macros is desirable.
Experience Desired:
* Product development and design experience- Experience working in an R&D environment (pharmaceutical or medical device) or a Clinical laboratory would be advantageous.
* Understanding of the requirements of quality management systems- ISO13485 & 21CFR820
* Knowledge of Non Conformance, Change Control and CAPA systems #LI-CB1
Share this job:
Share this Job
