CARBOGEN AMCIS is a leading service provider in the area of product and process development, including the commercial production of active ingredients for the pharmaceutical and biopharmaceutical industries. We have 4 facilities across Switzerland (Aarau, Hunzenschwil, Bubendorf, and Vionnaz), as well as locations in Riom (FR), Manchester (UK), Shanghai (CN) and Veenendaal (NL). Our success is based on the high professional and personal competence of our employees.
We are looking for a :
Corporate Senior CSV Specialist
To strengthen the corporate quality team. This position can be home-office based in any country, preferably where one of our site is based. The jobholder will regularly travel to the different sites in order to work with the local teams.
In this exciting role, you will be the main responsible person for the compliant qualification and validation of all existing and new electronically supported systems. Your responsibility will be to guide the system owners through the qualification, validation and the life cycle of computerized systems and assures its compliant execution according to the applicable guidelines and standards.
You will also be the process owner of all Corporate CSV processes and develop, maintain and train all policies, SOPs and instructions related to CSV. You will initiate and lead an inter site project team to improve data governance and data integrity according applicable international, corporate and internal standards.
You represent CSV and Data Integrity processes and data integrity topics as a subject matter expert in audits if required and on top of that, you play a consultancy role for the system owner but also IT, QA and Q-Systems.
The successful candidate will bring the following skills:
Are you interested in joining a dynamic corporate quality team and work in a growing organization within an international environment? We are looking forward to receive your application!