Specialist Quality Assurance
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 an Specialist Quality Assurance will include:
- Reviewing batch records of clinical supplies which are packaged locally and at CMO, working environment with multiple stakeholders in multiple countries.
- Review, and releasing of 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, 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 area of improvements.
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 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.