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Validation Specialist Audit Trail

Switzerland   •  Contract/Temporary, Full time

QLS are recruiting for a Validation Specialist to join an important project with a Global Pharmaceutical Company at their site based in Bern on a contract basis until end of September 2022 with option of an extension.
Main 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

Candidate?s Requirements:
? Degree in a Life Sciences/ 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, German is a plus

For more information or to apply for this position, please contact Adrien on 0041 (0) 800 106 106 or email aguimard@ckqls.ch. Please could you send any correspondence in English. Please quote reference QLS 00052148 in all correspondence.

You must have the right to work in Switzerland.

  • Agency: CK Group
  • Contact: Adrien Guimard
  • Phone: 01438 723 500
  • Reference: 52148
  • Posted: 12th November 2021
  • Expires: 10th December 2021

CK Group

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