Corporate Senior CSV Specialist

Advice and support for projects with Corporate GxP-relevant computer systems and support the system owners of computer systems in life cycle management. Review of qualification/validation documents for new and existing GxP-relevant computerized systems, software and electronic equipment steering according to applicable cGxPs. Review and evaluation of change applications, deviations and related CAPAs concerning validation, qualification and life cycle management of computerized system and data integrity. Risk assessment and risk mitigation of computerized systems related to data integrity.

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 St-Beauzire (FR), Manchester (UK), Shanghai (CN) and Veenendaal (NL). Our success is based on the high professional and personal competence of our employees.

• At least 5 years of experience in the validation of GxP-relevant IT systems such as ERP, LIMS, analytics systems or in process automation

• Sound knowledge of cGxP requirements for pharmaceutical companies

• Degree in sciences (MSc/BSc in e.g. computer science, chemistry, process engineering) or a science education with relevant professional experience

• Business-fluent English