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Specialist Quality Operations (m/w/d) 100% [16737]

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Nemensis AG
Specialist Quality Operations (m/w/d) 100% [16737]

At nemensis ag, we connected thousands of applicants with their dream jobs and gave them the opportunity to develop or re-enter the job market. For our client, an international company in Schachen, we are in search for a Specialist Quality Operations.

  • Employment type: Temporary via nemensis ag, 100%
  • Duration: asap - 05.07.2024
  • Salary: CHF 42 - 51.- / h gross

Your responsibilities:

  • Apply critical decision making, project management skills.
  • Provide guidance, consulting, interpretation of GMP and regulatory requirements or standards.
  • Build collaborative working relationships and effective communications with all stakeholders in all manufacturing operations, analytical testing, quality systems, regulatory, etc. at all levels.
  • Ensure deviations are investigated and resolved (within quality as well as functional areas). Lead investigations using root cause analysis techniques, ensure effective corrective actions and preventive actions.
  • Support, review and approve as needed the change management program (Change Control).
  • Provide guidance and support on equipment qualification, SDLC, raw material release activities, environmental monitoring, as well as support of utilities functions.
  • Perform SOP review and approval within Quality and for functional area procedures.
  • Participate in the release or rejection of GMP materials and components either through direct batch release support or involvement with critical program issues.
  • Conduct all work meeting high standards for quantity, integrity, quality, and GMP compliance.

Your Profile:

  • A Master's Degree in Engineering, Sciences or related field and at least five years of experience in the pharmaceutical, biotech or another regulated industry.
  • Experience with formal problem solving techniques and a hands-on approach to problem solving, such as Root Cause Analysis and/or Lean Six Sigma tools
  • cGMP experience in a sterile, vaccine, bulk or finished goods pharmaceutical environment
  • Detailed understanding of Critical Process Parameters, Critical Quality Attributes and general principles of equipment qualification
  • Experience in pharmaceutical, biotech or other regulated industry
  • Technical writing experience, i.e. investigations, laboratory reports, standard operating procedures, batch records, or protocols

Customer benefits:

  • 5 weeks vacation
  • Monthly salary
  • 40 hour week

We look forward to receiving your application!

For further questions please contact:

Nicolas Gerster

+41 61 205 98 69

Click to send email

Address

Nemensis AG

About the company

5,0 (1 review)

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