Job Detail

To extend our team in Switzerland, we are looking for a Qualification & Validation Engineer, to perform validation and qualification activities. you will be in charge of assuring compliance of these activities with cGMP as well as with internal policies and procedures.

Responsabilities:

• May be assigned Subject Matter Expert role for a defined validation/qualification area.


• Develop and justify the validation approach based on risk and scientific rational


• Ensure equipment, systems and processes are qualified, validated and maintained in compliance with local policies, guidelines, and procedures.


• Author and when required review validation documents, including requirement specifications, validation plans, protocols, reports, traceability matrix and summary reports.


• Contributes to the development and maintenance of the site procedures.


• Lead risk assessments and risk management teams


• Review change controls and maintenance interventions, evaluating the impact upon qualified systems & validated processes, and documents required actions


• Co-ordinate qualification and validation execution activities, including external vendors and internal departments.

profile:

• 5 years experience in pharmaceutical Validation or related field


• BS/MS in Engineering/Technical discipline or equivalent experience


• Experience in project management 


• Communicates pro-actively and collaboratively


• Team player: ability to interact effectively with team and customers


• Good level of English


• Ability to communicate in French