Beschreibung
A Global Life Sciences manufacturer based in Denmark is currently looking for an experienced Method Validation/Assay development specialist (ELISA) to act as a subject matter expert, on site, in line with an exciting new QA project.The responsibilities of the Method Validation/Assay development specialist (ELISA) are as follows:
* Working alongside the current QC team responsible for method validation and assay development techniques.
* Responsibility for ELISA acting as a subject matter expert during a busy period of QA projects.
* Generation and review of Analytical validation documentation within a highly regulated pharmaceutical/Biopharmaceutical environment.
To fulfil these requirements for the Method Validation/Assay development specialist (ELISA), you must have the following skills/experience:
* Experienced in QC method validation of analytic chemistry methods.
* Experience of IQ and validation of ELISA, preferably by using retrospective data and the composition of Documentation according to quality system requirements.
* Knowledge of ELISA techniques within a highly regulated GMP environment working within the parameters of FDA legislation.
* Educated to degree level/equivalent experience.
* Excellent communication and presentation skills.
The successful Method Validation/Assay development specialist will have the chance to work in a very reputable company within the life sciences industry during a very exciting QA project and receive competitive rates of pay.