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Quality Auditor - II - P2

Quality Auditor - II - P2

CK GroupLucerne
30+ days ago
Salary
CHF 42.55–CHF 51.71 hourly
Job description

Quality Auditor - II - P2

Job Title : Specialist Quality Assurance

Work Location : Lucern

Country : Switzerland

Duration : 12 months

Rate : CHF 42.55 phr - CHF 51.71 phr (8 hours per day) depending on experience

Your main duties as a Specialist Quality Assurance will include :

  • Reviewing batch record of clinical supplies which are packaged locally and at CMO, working cross-functionally with multiple stakeholders in multiple countries.
  • GMP reviewing of the batch records and reviewing of the regulatory filings and the final release.
  • Collaborating closely with our internal functional areas (i.e. GMP Manufacturing & Packaging & Logistics, Comparator Planning, Clinical Quality, Clinical Research Associates, Central Complaint Handling Unit, Batch releasing Quality) and external partners (i.e. Contract Manufacturing Organizations,).

Additional duties will include :

  • Review, and release of clinical finished goods, including review of the printed and applied label.
  • Communicate batch related issues to management, EU Qualified Persons and the Swiss Responsible Person.
  • Review and release of incoming label stock.
  • Your Background :

  • Bachelor’s or Master’s Degree in life sciences required, ideally in biotechnology, biology or pharmaceutical studies.
  • Master’s Degree in clinical research, clinical data or clinical analysis is also advantageous.
  • Minimum of 2-years’ experience in GMP environment within the pharmaceutical business or comparable.
  • Experience in batch record review is advantageous.
  • Preferably SAP and MS Word / Excel Experience.
  • English and German language – Proficiency at a business level is necessary.