CK Group: Specialist Quality Assurance
vor 1 Monat
Job Title: Specialist Quality Assurance
Work Location: Lucerne
Country: Switzerland
Duration: 12 months
Rate: Up to CHF63 phr (8 Hours per day)
Your main duties as a Specialist Quality Assurance will include:
- Reviewing batch records of clinical supplies which are packaged locally and at CMO, working in an environment with multiple stakeholders in multiple countries.
- Reviewing and releasing clinical finished goods, including reviewing of the printed and applied label.
- GMP reviewing of the batch record and reviewing of the regulatory filings and the final release.
Additional duties will include:
- Collaborating closely with internal functional areas, such as GMP Manufacturing & Packaging & Logistics, Comparator Planning, Clinical Quality, Clinical Research Associates, Central Complaint Handling Unit, and Batch releasing Quality.
- Communicating batch-related issues to management, EU Qualified Persons, and the Swiss Responsible Person (FvP).
- Supporting in Quality Walkdowns, GEMBA walks and/or Walkthrough Audits of GMP areas/on the shop floor to sustain continuous improvements efforts, ensure quality compliance and/or identify potential areas of improvement.
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 a GMP environment within the pharmaceutical business or comparable.
- Experience in batch record review is strongly recommended.
- Demonstrated problem-solving skills, preferably with Six Sigma Tools.
- Preferably SAP and MS Word/Excel Experience.
Languages: Good level of English (C1), German is an added benefit.
Apply: It is essential that applicants hold entitlement to work in Switzerland. Please quote job reference 107671 in all correspondence.
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