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Validation Specialist - CSV (Pharma)

Experis AG

Posted on Nov 13, 2021 by Experis AG

Bern, Switzerland
Immediate Start
Annual Salary

Validation Specialist - CSV (Pharma)

For our client, Switzerland's leading medical device company, we are looking for a Validation Specialist with experience in CSV within the GMP environment. This is initially a 12-month contract, with extension possibility, based in Bern, Switzerland.

Tasks & Responsibilities:

  • Support closing a CPA regarding audit trail review for QC equipment
  • Categorize all QC GxP systems according to global SOP and define the frequency of System Audit Trail review based on risk.
  • Perform a System Audit Trail review for those systems that require it based on their categorization.
  • Set up a maintenance task in SAP to plan subsequent reviews

Must Haves:

  • Degree in a LifeSciences/Biotechnology, Chemistry discipline or comparable work experience
  • Several years of experience in computerized system validation (CSV) in a GMP environment and good knowledge of related regulatory requirements in the life sciences industry (GAMP 5, 21 CFR part 11)
  • Good understanding of analytical technologies
  • Strong analytical thinking and problem-solving ability
  • Excellent communication and teamwork skills
  • Ability to simultaneously support multiple projects, duties and assignments and prioritize accordingly
  • Excellent writing skills for scientifically sound technical documents, instructions, protocols and reports.
  • Self-dependent way of working and taking ownership of assigned task to plan and deliver according to agreed timelines.
  • Good verbal and written skills in English

Nice to have:

  • German language skills

General Information:

  • Duration: 12 months
  • Extension: possible
  • Location: Bern, Switzerland
  • Workload: 100%

Interested in this opportunity? Kindly send us your CV today through the link in the advert. Should you have any questions please contact Nastasia Whyte.

Reference: 1397162189

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