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Contractor Quality Assurance Generalist (f/m/d)

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Solothurn/Biel, Switzerland | 
Temporary Employment
Job title: Contractor Quality Assurance Generalist
Industry:  Pharma
Skills:  Qualification / Validation QM, Quality Assurance, Manufacturing
Start of project: 01.05.2024 - 01.06.2024
Duration of the project : 6 months
Project volume: 1008 Hour(s) 
Location: Solothurn/Biel, Switzerland

Tasks:
  • Manages material introduction, supplier qualification, and component management, setting up quality and regulatory strategies on site.
  • Coordinates site inspections, oversees transformation for new production, and ensures readiness for client and regulatory audits.
  • Monitors local regulation updates, conducts gap analysis, and ensures site practice meets regulatory requirements.
  • Leads quality agreement processes with customers, suppliers, and service providers; drives Quality Management Review and continuous improvement initiatives.
  • Administers Quality Risk Management, maintains the Quality Risk Register, and participates in cross-functional projects to enhance site quality and client experience.
  • Engages in hosting client and regulatory audits, ensuring timely and effective execution of audit commitments.
  • Collects quality data, analyses compliance performance trends, and identifies opportunities for continuous improvement.

Qualifications:
  • At least Bachelor's degree in Chemistry, Biology, Pharmacy, or related field; additional certifications in Quality Assurance or Regulatory Affairs preferred.
  • Minimum 5 years of Quality Assurance experience in CDMO companies, with a track record in introducing new quality processes, risk management.
  • Practical knowledge in GMPs and Regulatory Compliance.
  • Strong understanding of regulatory compliance in pharmaceutical or biotech industries; experience in fixing compliance issues.
  • Proven expertise in creating and maintaining quality documentation, including SOPs, quality agreements, and regulatory submissions.
  • Demonstrated problem-solving and analytical skills, with the ability to drive continuous improvement initiatives.
  • Experience in leading cross-functional teams and participating in client and regulatory audits.
  • Excellent communication skills, both written and verbal.

Reference number: 14582
Industry: Pharma
Project start: 01.05.2024 - 01.06.2024
Duration: 6 months
Employment type: Temporary Employment
Contact
Pawel Jasionek
p.jasionek@aristo-group.ch
+41 44 274 39 00
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