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Quality Assurance Analyst
1 week ago
Company Overview:
F. Hoffmann-La Roche Gruppe is a leading research-focused healthcare group, with over 100,000 people across 100 countries working together to push back the frontiers of healthcare.
Job Description:
We are seeking a Quality Assurance Analyst to join our team in ensuring the quality and compliance of our pharmaceutical products. The successful candidate will be responsible for performing testing of EM / product stream samples to meet product release timelines and in accordance with cGMP regulations and Roche/Genentech standards.
Key Responsibilities:
- Perform routine and ad-hoc environmental monitoring (EM) works associated with HVAC/BSC/VLFH/HLFH monitoring, compressed air/gas, personnel monitoring, water and clean/pure steam sampling.
- Support manufacturing operations by timely completion of testing and disposition.
- Continuous improvement of processes and technology to drive right first time and efficiencies.
Technical Requirements:
- Perform EM which includes HVAC/BSC/VLFH/HLFH monitoring, compressed gas, personnel monitoring, water and clean steam sampling in accordance to cGMP procedures.
- Perform testing and review of routine and non-routine environmental, raw material, product related samples in accordance to the Standard Operating Procedures (SOP) and Test Methods (TM).
- Documentation and review of results in the Laboratory Information Management System (LIMS) and/or documents in accordance with cGMP Procedures.
Safety and Health:
The ideal candidate will embody PT behaviors, lean principles and methods while fostering a continuous improvement mindset throughout the organization by encouraging experimentation and learning.