Corporate Senior CSV Specialist (m/w/d)

Carbogen AMCIS AG; Schweiz; Vor Ort; 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

We are currently offering an interesting opportunity as Corporate Senior CSV Specialist (m/f/d) for a 2 years contract, at our location inBubendorf, Switzerland, with flexibility to be based at one of our other Swiss locations, such as Aarau or Neuland. If you are looking for a varied and exciting new professional challenge, we are happy to receive your application.

Your responsibilities:

• 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

Your profile:

• 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
• A dynamic highly motivated work environment and a high value infrastructure
• Possibility to enhance, increase and further develop you key competences
• Option to work partly from home
• 5 weeks holiday at minimum
• Contribution to children's day care
• Insurance covering private travels
• 13th Salary, Social security to 100% covered by CARBOGEN AMCIS
• Bonus Program

We look forward to receiving your application!

Note for recruitment agencies: We do not accept unsolicited applications from recruitment agencies for this position. Unsolicited applications from recruitment agencies will be deleted and not be processed further. Thank you for your understanding.

• 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. Learn more about careers opportunities at CARBOGEN AMCIS at: www.carbogen-amcis.com/careers