Quality Assurance Specialist
Quality Assurance Specialist
Jobdescription
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
Marta Bartkowiak
About the company
