Beschreibung
Laboratory/QC Technician HPLCOur pharmaceutical client is currently undergoing preparations for a new commercial product to be submitted for USA market. They are looking for a laboratory technician to support them in the preparation of documentation for the FDA submission. The project aims to review all production methods to ensure that they are up to date and compliant with FDA requirements.
Job and Project Description
- Perform an analytical validation study using the HPLC method (water method, utilising empower software).
- Work to appropriate laboratory systems, standards and procedures, e.g. data recording, labelling, investigation and calibration procedures. Complete analytical documentation including the input of results onto the LIMS system.
- Maintain good laboratory housekeeping at all times.
Requirements
- Education in life science / chemistry / pharmaceutical sciences or relevant experience.
- Experience as a Laboratory Technician in a sterile pharmaceutical laboratory.
- Some knowledge of cGMP and FDA regulatory requirements for testing and stability pertaining to the pharmaceutical industry.
- Experience of running a validation study.
- Experience of HPLC analytical methods, HPLC water methods a distinct advantage.
- Previous use of empower software an advantage.
- Experience in documentation of analytical results and test study data.