Quality Auditor

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Job Title : Specialist Quality Assurance

Work Location : Lucern

Duration : 12 months

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.