Job Description

Roche fosters diversity, equity and inclusion, representing the communities we serve. When dealing with healthcare on a global scale, diversity is an essential ingredient to success. We believe that inclusion is key to understanding peoplexe2x80x99s varied healthcare needs. Together, we embrace individuality and share a passion for exceptional care. Join Roche, where every voice matters.The PositionSenior Quality Control SpecialistA healthier future. Itxe2x80x99s 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.Thatxe2x80x99s what makes us Roche.As the Senior Quality Control Specialist for Roche Singapore Technical Operations, you are part of the Microbiology /Environmental Monitoring 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.Your opportunityTesting and Review: Routine and non-routine environmental, raw material, and product-related samples are tested and reviewed according to SOPs and Test methods.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.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 RSTOxe2x80x99s Safety, Health & Environmental (SHE) requirements are complied with, and any workplace accidents, near misses, and hazards are reported promptly.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 areYou hold a a degree in Microbiology, Biology, Biochemistry, or any Life Sciences discipline, or an equivalent qualification with 5 years of related work experience, preferably in a biotech or pharmaceutical operating environment.Proficient in cGMP relevant to the pharmaceutical industry and familiarity with laboratory safety procedures.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.Who we areAt Roche, more than 100,000 people across 100 countries are pushing back the frontiers of healthcare. Working together, wexe2x80x99ve become one of the worldxe2x80x99s leading research-focused healthcare groups. Our success is built on innovation, curiosity and diversity.Roche is an Equal Opportunity Employer.

Roche