Senior CSV Specialist – GxP Validation & Lifecycle Lead

Carbogen AMCIS AG; Schweiz; Hybrid; EUR 107.515 - 150.521; Vollzeit

Benefits dieser Stelle

5 weeks holiday

Childcare support

13th Salary

Bonus Program

Private travel insurance

Zusammenfassung

CARBOGEN AMCIS is seeking a Corporate Senior CSV Specialist (m/f/d) for a 2-year contract at our Bubendorf location, with the possibility to base yourself at Aarau or Neuland in Switzerland.

You will review qualification/validation documents for GxP-relevant computerized systems, support system owners in life cycle management, and evaluate change controls and CAPAs to ensure data integrity and cGxP compliance.

Qualifikationen

• 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 or a science education with relevant professional experience.

Aufgaben

• 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.

Kenntnisse

GxP IT validation

Risk assessment

Life cycle management

Ausbildung

BSc/MSc in CS/Chemistry/Process Eng

Jobbeschreibung

CARBOGEN AMCIS is seeking a Corporate Senior CSV Specialist (m/f/d) for a 2-year contract at our Bubendorf location, with the possibility to base yourself at Aarau or Neuland in Switzerland.

You will review qualification/validation documents for GxP-relevant computerized systems, support system owners in life cycle management, and evaluate change controls and CAPAs to ensure data integrity and cGxP compliance.