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Job Details
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Validation Consultant- Basel- Contract



Business Type: Pharmaceutical Company, Biotechnology Company, Drug Development Company
Job Type: Quality Assurance - Control, Validation
Job Level: Experienced (non manager)
Position: Contract
Location: Switzerland
Reference: 18112019
Closing Date: 02/12/19
Job Details:

I am looking forward to speaking to talented and responsible CSV Specialist to join my client, a world leading pharma 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 Computerized 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

  • Ensure computerized system validation strategy within QC department as well as providing laboratory equipment validation expertise
  • 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 computerized 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 (AIQ)
  • Oversee qualification activities executed by QC analysts, provide training and support
  • Coordinate instruments periodic review
  • Support and prepare inspections, audit responses and regulatory submissions

Education & Experience

  • Bachelor or engineering degree in a technical field
  • Min 5 years of experience in Analytical Instrument Qualification (AIQ) and Computerized 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

If you are up for the challenge, send your profile across to Alex at a.arjocan@nonstopconsulting.com so he can give you more details about the role!

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: 18/11/2019 | NPJ Ref: 245387
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