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Quality Assurance Analyst

1 week ago

Singapore F. Hoffmann-La Roche Gruppe Full time

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.