Description
Our client, a pharmaceutical company based in Switzerland and specialising in manufacturing highly active pharmaceutical ingredients is looking for a Qualification/Validation Engineer to support their projects on site.Tasks:
•Responsible for co-ordinating and performing qualification of pharmaceutical-chemical equipment for the production of active pharmaceutical ingredients.
•Planning and monitoring of documentation of equipment reviews / equipment qualification - Drug Substance equipment.
•Assessment and approval of changes to systems in Drug Substance
•Assurance, control and enforce the quality policy as well as cGMP, ICH, PIC-GMP and internal quality requirements within the organisation in the field of Drug Substance.
Experience:
•Completed chemistry or chemical engineering degree
•Proven relevant experience in a regulated environment in the chemical and pharmaceutical industry and in plant qualification
•Good knowledge of regulatory requirements (cGMP, ICH, ISO, etc.)
•German and English language skills (oral and written)