QA Specialist (Clinical Supplies) 100% (a)Michael Page

We are currently recruiting for our client, a leading international company active in the pharmaceutical sector, with modern offices in the canton of Lucerne, a QA Specialist 100% (d/f/m) in a temporary position starting asap for the next 12 months, with the option of extension or take-over. Candidates who can immediately are strongly preferred.

Hybrid work model.

The Quality Specialist (d/f/m) ensures that every single material inside our products is manufactured, processed, tested, packaged, stored and distributed aligned with our incredibly high standards of quality and meets all regulatory requirements (for the Clinical Supplies Team). In this position the selected candidate will be responsible for the following task area:

• Reviewing and releasing of incoming label stock, clinical finished goods, including review of the printed and applied label
• Logbook reviews and GMP review of the batch record and review of the regulatory filings and the final release
• Collaborating closely with 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)
• Communicating batch related issues to management, EU Qualified Persons and the Swiss Responsible Person (FvP)
• Supporting Quality Walkdowns, GEMBA walks and/or Walkthrough Audits of GMP areas/on the shop floor to sustain continuous improvements efforts, ensuring quality compliance and/or identifying potential area of improvements

In order to be considered for the role, the selected candidate must have:

• 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 or related industry
• Experience in batch record review is strongly recommended
• Excellent understanding of GMP and GDP
• High sense of accuracy and very good time management skills
• Professional and precise communication to local and global stakeholders in English; German is a big advantage
• Proficiency with SAP and MS Word/Excel as well as Six Sigma tool is preferred
• Willingness to drive issue-resolution