QA Operations Representative

Vor 4 Tagen


Neuenburg, Schweiz SII Group Switzerland Vollzeit

1 week ago Be among the first 25 applicants

SII Group is a trusted technology partner, providing high value-added solutions for the IT projects of many large corporations. Since its founding in 1979, the Company has been providing solutions adapted to its clients’ needs by relying on:

Its acknowledged expertise in various industries and sectors
Proven 'turnkey' solutions
Adaptable, evolving services

Today, with a staff of more than 18,000, SII Group supports companies across 20 countries.

At SII Switzerland, we pay attention to the personal and professional wellbeing of our employees. We place our collaborators at the heart of our actions and activities. If you are motivated by the perspective of joining a big, trusted, and recognized group, then let's meet

To develop our consulting offer and support one of our clients, we are looking for a talented QA Operations Representative.

Missions

  • Participate as Quality Validation representative to the site and global project implementation.
  • Provide quality and compliance support for validation activities associated with equipment qualification, Utilities qualification, Room qualification, and/or Computerized System Validation experience (CSV), cleaning validation, and/or process validation to ensure conformance to cGxPs.
  • Collaborate with project teams to identify and resolve quality issues, plan and organize QA activities accordingly.
  • Review and approve design documents supporting the qualification/validation and manufacturing routine activities.
  • Review/approve deviations, problem/defect, incident, and changes that occurred during qualification/validation of equipment/systems.
  • Promote compliance with data integrity and computer system validation requirements and regulations.

Profile

  • Bachelor's degree in Sciences or a related field.
  • 5+ years in Quality Assurance or Quality Control in the pharmaceutical industry.
  • Good understanding of solid oral dosage form manufacturing, packaging, and QC processes is a plus.
  • Experience with Change Control, Deviation Management, Risk Management Quality Systems.
  • Experience in Quality end-to-end processes.
  • Understanding of Electronic Batch Record (MES) or System Applications and Products in Data Processing (SAP).
  • Experience in qualification/validation of systems.

For information

  • Location: Neuchatel - CH
  • Language: Fluent in English and French
  • European nationality
Seniority level
  • Associate
Employment type
  • Full-time
Job function
  • Information Technology
Industries
  • IT Services and IT Consulting
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