Corporate Senior CSV Specialist

Corporate Senior CSV Specialist

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.

 

Responsibilities:

  • Advice and support for projects with Corporate and local 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.
  • Responsible for the further development of policies and processes for CSV (continuous improvement of the corporate procedures and processes related to validation, qualification and life cycle management of computerized system).
  • Review and evaluation of change applications, deviations, audit observations 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.
  • Support capital projects with CSV expertise working in conjunction with specific project teams.

 

Requirements:

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

The successful candidate will bring the following skills:

  • Leadership skills, self-responsive, reliable.
  • Precision and accuracy in all work steps.
  • Good computer skills.
  • Good communication and coordination skills and experience of working in multi discipline teams.
  • Good intercultural and language skills: English is a must, German and/or French are a plus.
  • Ability to work in multi-cultural environment

 

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!

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