drjobs Quality Auditor - II - P2 العربية

Quality Auditor - II - P2

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Job Location drjobs

Lu - Italy

Monthly Salary drjobs

CHF CHF CHF 42.55

Vacancy

1 Vacancy

Job Description

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.

Apply

It is essential that applicants hold entitlement to work in Switzerland. Please quote job reference 106774 in all correspondence.

Employment Type

4

Company Industry

Science & Research

About Company

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