A healthier future. It’s what drives us to innovate. To continuously advance science and ensure everyone has access to the healthcare they need today and for generations to come. Creating a world where we all have more time with the people we love.
That’s what makes us Roche.
As the Senior Quality Control Specialist for Roche Singapore Technical Operations, you are part of the Micro/EM Team, playing a key role in timely and compliant performance of testing for EM/product stream samples, which supports manufacturing operations, drives process improvements, and aids in investigations of microbial contamination, all in accordance with cGMP regulations and Roche/Genentech standards.
The Opportunity
- Testing and Review: Routine and non-routine environmental, raw material, and product-related samples are tested and reviewed according to SOPs and TMs.
- Prepare EM reports / trend graph for product lot release and trend data analysis.
- Documentation: Results are documented and reviewed in the LIMS and/or documents following cGMP Procedures.
- Lab Support: General lab support includes housekeeping, equipment maintenance, document archival, maintaining logbooks, and inventory of lab supplies.
- Problem Solving: Issues related to testing and equipment are solved and troubleshooted.
- Training: Other analysts are trained on methods and/or SOPs, and all training required to support/perform GMP activities are completed timely.
- Continuous Improvement: Lead the continuous improvement of laboratory procedures and processes to ensure compliance to GMPs.
- Safety Compliance: All RSTO’s Safety, Health & Environmental (SHE) requirements are complied with, and any workplace accidents, near misses, and hazards are reported promptly.
- Biosafety Officer Role: Support line management in all matters concerning biosafety, harmonize biosafety practices on site, and maintain an updated inventory of all areas where biological materials are stored or used.
- Leadership: Work cooperatively with the Head of Micro/EM and QC Supervisor to create a strong team spirit, promote a positive safety culture, and embody PT behaviors and lean principles while fostering a continuous improvement mindset throughout the organization.
- Initiate and assess discrepancy records, identify necessary corrective actions, lead or support investigations and studies, and participate or lead in QC or cross-functional projects including method validation, method transfer, equipment qualification, and process improvement projects.
Who You Are
- You hold a a degree in Microbiology, Biology, Biochemistry, or any Life Sciences discipline, or an equivalent qualification with ideally a minimum of 5 years of related work experience, preferably in a biotech or pharmaceutical operating environment.
- Proficiency in cGMP relevant to the pharmaceutical industry and familiarity with laboratory safety procedures.
- The ability to determine when to escalate issues and minimal guidance required on routine work.
- Demonstrated ability to organize and plan effectively, excellent verbal and written communication skills in English, and a reliable and collaborative team player.
