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For our client, a pharmaceutical company based in Lucerne, we are looking for a Quality Assurance Specialist.

In this role the QA Specialist will review batch record of clinical supplies which are packaged locally and at CMO. This position offers a thrilling cross functional work environment with multiple stakeholders in multiple countries. 

General Information:

• Start Date: ASAP
• Duration: until 30.06.2025
• Workload: 100%
• Workplace: Lucerne

Responsibilities include but are not limited to:

• Review and release of incoming label stock
• Review, and release of clinical finished goods, including review of the printed and applied label
• GMP review of the batch record and review of the regulatory filings and the final release
• Collaborate 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,). 
• Communicate batch related issues to management, EU Qualified Persons and the Swiss Responsible Person (FvP).

Your profile:

• 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.
• Excellent experience with Good Documentation Practices.
• Demonstrated problem-solving skills, preferably with Six Sigma Tools 
• Preferably SAP and MS Word/Excel experience.
• English and German language - Proficiency at a business level is necessary.
• Time-management skills to deliver by agreed deadlines, as well as high sense of responsibility.
• Willing to drive issue resolution
• Excellent communication, writing, and presentation skills.
• Demonstrated ability to effectively collaborate and influence internal and external stakeholders.
• Excellent analytical and problem-solving skills.
• Excellent team player