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Job Details
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Validation (CSV) Specialist - Basel - Contract



Business Type: Pharmaceutical Company, Biotechnology Company, Contract Research Organisation, Drug Development Company, Contract Manufacturing
Job Type: Quality Assurance - Control, Validation
Job Level: Experienced (non manager)
Position: Contract
Location: Switzerland
Reference: 2511191707
Closing Date: 09/12/19
Job Details:

I am looking forward to speaking to talented and responsible Validation Specialist to join my client, a world leading research organisation that is going to offer a lot of professional development and learning opportunities, as well as opening future career doors.

You would be accountable for the laboratory instruments qualification, including Computer System Validation (CSV) in the QC laboratories and would also support the deployment of Data Integrity (DI) in the department, offering you cross funtional resposibilities that are going to expand your network globally whilst learning from the best!

Essential duties and responsibilities

  • Comply with GMP and Data Integrity requirements through applicable guidelines and procedures
  • Define and follow-up the CS Validation Strategy (Validation Plan)
  • Review / Approve User System Requirement (URS), Functional Specification and Design Specifications
  • Lead Risk Assessments
  • Write Design Qualifications
  • Writing qualification protocols (IOPQ) and reports for quality control instruments, including computer systems
  • Ensure the readiness of instruments for validation activities (i.e. with feasibility protocols)
  • Support analytical technical transfer of assays requiring Analytical Instrument Qualification activities
  • Oversee qualification activities executed by QC analysts, provide training and support
  • Support and prepare inspections, audit responses and regulatory submissions

Education & Experience

  • Bachelor or engineering degree in a technical field
  • Min 5 years of experience iInstrument Qualification and Computer System Validation (CSV) activities
  • Experience in GMP laboratory activities and good knowledge of Data Integrity requirements
  • Fluent in German and English (C1 written and spoken)

Qualifications

  • Excellent computer skills (Word, Excel, Power Point, MS Project)
  • Able to set his/her own priorities and tight timelines
  • Good interpersonal, organizational, and communication skills

We have limited interview slots for the next days, so if this is of interest, apply today to give yourself the best chance.

The job market changes very quickly so do not forget to connect with me on LinkedIn, check other roles that I am hiring for at the moment and follow for any future relevant roles.



Posted: 25/11/2019 | NPJ Ref: 245727
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