Quality Assurance Specialist

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. 
This job requires a high sense of accuracy and very good time management skills which essential to ensure timely supply of the clinical drugs to patients. Prompt, professional and precise communication to local and global stakeholders is key.

General Information:
 

• Start Date: ASAP / 01.12.2024
• Duration: 1 year contract
• Extension: possible, to be discussed
• Workload: 100%
• Workplace: Schachen
• Home office: possible, to be discussed

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).
• Logbook reviews.
• Support 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 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 strongly recommended.
• Excellent experience with Good Documentation Practices.
• Demonstrated problem-solving skills, preferably with Six Sigma Tools 
• Preferably SAP and MS Word/Excel experience.
• English proficiency at a business level is necessary, German is nice to have.
• 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