Specialist Quality Assurance

  • Salary: Competitive
  • REF Number: v-108018
  • Consultant: Robert Angrave
  • Contact: 01246 457716
  • Date Published: 30.10.2024
  • Industry: Pharmaceutical
  • Location: Lucerne, Switzerland
  • Functional Expertise: Quality Assurance

CK QLS are working with a leading multinational pharmaceutical company based in Lucerne, Switzerland, who are looking for a Specialist Quality Assurance, to support our clients Clinical Supplies Quality Team on a 12 month contract basis.

 

Your main duties as a 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 108 018 in all correspondence.

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