Roche

GxP Support Specialist

Roche

full-time

Posted on:

Location Type: Office

Location: Basel • 🇨🇭 Switzerland

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Job Level

Mid-LevelSenior

About the role

  • Ensure compliance with all GxP requirements within Logistic Solutions in Basel and Kaiseraugst
  • Handle deviations and changes within the GxP environment
  • Actively represent GxP logistics processes during customer audits and inspections
  • Collaborate with quality functions and act as an interface to business functions
  • Support Logistic Solutions business circles on all GxP-related matters
  • Implement GxP processes and manage process documentation
  • Support audits and inspections and present the relevant GxP processes

Requirements

  • Completed vocational training or a bachelor’s/master’s degree, ideally in the pharmaceutical industry or pharma logistics
  • Preferably several years of professional experience in the GMP/GDP area and a strong affinity for logistical processes
  • Experience in GxP deviation and change management
  • Experience presenting during GxP customer and regulatory inspections
  • Experience handling GxP documentation
  • Interest in technical workflows and affinity for working with IT systems; knowledge of CSV (Computer System Validation) is an advantage
  • Excellent German skills (min. C1) and English skills (B2) in spoken and written form
  • High degree of structured and independent working style combined with strong customer orientation and a professional, proactive approach with all stakeholders
  • Excellent team and interpersonal skills and a team-oriented mindset
  • High level of proactivity and personal responsibility in an open and collaborative environment
Benefits
  • Appreciation for individual expression and open communication
  • Opportunity to collaborate with team members and external partners

Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard skills
GxP complianceGMPGDPGxP deviation managementGxP change managementGxP documentationComputer System Validation (CSV)logistical processesprocess documentationauditing
Soft skills
structured working styleindependent working stylecustomer orientationproactive approachteam-oriented mindsetinterpersonal skillscommunication skillscollaborative environmentpresentation skillsstakeholder management
Certifications
bachelor's degreemaster's degreevocational training