Beschreibung
* Luzern, Luzern
* Temporär
Job Details
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
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