145 days ago on wega-it.com

CSV Consultant (permanent)

wega Informatik AG

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 Please refer to JobSuchmaschine in your application

CSV Consultant (permanent)

CSV Consultant (permanent)

Experienced CSV Consultant (permanent)

We are a Life Science and IT service provider that has been successfully carrying out ‘state-of-the- art’ projects for international customers since more than 20 years. Our consultants work in

- our offices in Basel,
- sometimes in Home-Office
- sometimes in our customer’s premises.

We pride ourselves on being a dynamic forward thinking organization. We are looking for like-minded individuals with ambitions and highly motivated by interesting jobs, as well as financial incentives.
Are you r eady for the next step and challenge in your career? Do you enjoy working in an environment that values it´s employees? If yes, then it is probably the right time to move on and apply for a permanent Job @wega.

 

Role:

  • Act as a CSV consultant in various IT projects in Switzerland/Germany for customers in the pharma industry.
  • Responsible for writing, reviewing and approving the needed documents in accordance to the customer QMS and regulatory
  • Support/Moderate Risk assessment sessions to help identifying risks associated to an IT system and support/monitor execution of associated mitigations.
  • Support testing, documentation and change management activities.
  • Interact with all project stakeholders (Business Owner, System Owner, Test Team) as a central project member.

 

Capabilities:

  • More than 3 years experience in SW Quality Management, SW Testing, CSV or another quality assurance area within a regulated industry.
  • General knowledge of GxP, 21CFRPart11, Annex 11, GAMP5. Experience in other regulated domain(s) accepted as well.
  • Excellent communication skills, very good written and spoken English and German
  • Willingness to travel (up to 30%)
  • Experience with Test Management Tool(s) is a plus (e.g. HP ALM)

 

We support you to continuously update your know-how regarding validation of computerized systems by attending courses or conferences.

Working Place:

Basel / Switzerland   (or Germany / Frankfurt area / partly Home office)

Interested?

Please send your application to  jobs@wega-it.com