QA Specialist

Beschreibung

QA Specialist

Stellenbeschreibung

You are responsible for managing all deviations, change controls and investigations associated with the manufacture of products
You will ensure that all activities comply with relevant regulatory, quality and customer requirements
Maintain systems to ensure that deviations and change controls are managed and approved in a timely manner in accordance with relevant procedures
Manage significant and complex deviations related specifically to the product portfolio
Manage significant investigations in accordance with approved procedures
Maintain systems to follow up and close out in a timely manner all relevant preventive actions
Investigate all product technical complaints and respond accordingly
Liaise closely with manufacturing to ensure timelines for change execution are met
Gewünschte Qualifikationen

Fluent English (written and spoken), German is an advantage
Experience in the pharmaceutical industry. Experience in QA Operations, production, QC and/or other relevant operational areas
Thorough knowledge of GxP QA requirements
Strong understanding of risk assessment and risk management fundamentals/tools
Technical understanding of pharmaceutical / biological processes
Team- and consensus-builder, with definitive decision making ability

Unternehmensbeschreibung

Our client is a young, dynamic IT system house in greater area of Basel. The company is in constant development, offering interesting projects. To expand the existing team we are looking for a QA Specialist.