
QC Specialist I
4 weeks ago
Establish and ensure testing of drug substance release and stability testing including all testing of intermediates in process. Control samples and lab operations are in accordance with written testing SOPs and local/international regulations.
Job Description Key Responsibilities- OOff/Deviation handling.
- CAPA definition - KPI trending - Ensure all activities in compliance with cGxP, incl. data integrity review and approval of analytical data / tests (analytical release). Stability - Stability testing (Projects) – protocol preparation, evaluation, report preparation.
- Reporting (Stability plan preparation, trend analysis, evaluation) - Performance of Stability studies, protocols and comparative reports for supplier qualification - Review and approval of analytical tests (analytical release) - Microbiological QC - Perform Microbiological testing of materials and utilities, environmental and personnel monitoring - Provide expert Support for site qualification and validation activities - Maintain and calibrate equipment incl. plan preparation - Support in supplier qualification - Trending and analysis of KPI/KQI - Support sample planning and sampling execution - Reporting of technical complaints / adverse events / special case scenarios related to Novartis products within 24 hours of receipt - Distribution of marketing samples (where applicable)
- Comply with all HSE guidelines
- Detect and report potential accident, risks and propose solutions
- Participate in HSE risk assessments
- Preparation and participation to internal HSE audits
- Responsible for participating in initial training and retraining
- Professional experience (6+ years) in the pharmaceutical sector or in the manufacture of active substances in analytical laboratories in a GMP environment or equivalent; Collaborating across boundaries; Functional Breadth; efficient inter and intra-departmental communications.
- Collaboration; result oriented. Breakthrough Analysis; Being Resilient; Operational Excellence; Continuous Learning; Digital & Tech Savvy
- MS Office applications and other standard IT applications supporting Quality activities
- Laboratory equipment; Quality Control (QC) Testing; Quality Control Sampling; Knowledge of TQM and related industry GxP standards and processes; Laboratory Excellence; Quality decision making
- Technical education & 3-5 years relevant experience or University degree in Microbiology, Biochemistry or equivalent + 0-4 years working experience.
- Continued Learning
- Dealing With Ambiguity
- Decision Making Skills
- Gxp
- Industry Standards
- Laboratory Equipment
- Laboratory Excellence
- Quality Control (Qc) Testing
- Quality Control Sampling
- Self-Awareness
- Technological Expertise
- Total Quality Management
-
QC Specialist I
4 weeks ago
Singapore Novartis Farmacéutica Full timeChoose LocationChoose Location# QC Specialist I (Microbiology)REQ- Sep 11, 2025Singapore### SummaryEstablish and ensure testing of drug substance release and stability testing including all testing of intermediates in process. Control samples and lab operations are in accordance with written testing SOP's and local/international regulations.### About the...
-
QC Specialist I
1 day ago
Singapore Novartis Singapore Full timeJoin to apply for the QC Specialist I - Analytical role at Novartis Singapore . This role is responsible for establishing and ensuring testing of drug substance release and stability testing, including testing of intermediates in process control samples. Laboratory operations must comply with written testing SOPs and local/international regulations. About...
-
QC Specialist I
4 weeks ago
Singapore Novartis Singapore Full timeSummary Establish and ensure testing of drug substance release and stability testing including all testing of intermediates in process. Control samples and lab operations are in accordance with written testing SOP's and local/international regulations. About The Role Key Responsibilities: OOx/Deviation handling . CAPA definition -KPI trending -Ensure all...
-
QC Specialist I
1 day ago
Singapore Novartis Singapore Full timeSummary Establish and ensure testing of drug substance release and stability testing including all testing of intermediates in process. Control samples and lab operations are in accordance with written testing SOP’s and local/international regulations. About The Role Key Responsibilities: OOx/Deviation handling . CAPA definition -KPI trending -Ensure all...
-
QC Specialist/ Senior QC Specialist
3 days ago
Singapore F. Hoffmann-La Roche AG Full timeQC Specialist/ Senior QC Specialist page is loaded## QC Specialist/ Senior QC Specialistlocations: Singaporetime type: Full timeposted on: Posted Todayjob requisition id: At Roche you can show up as yourself, embraced for the unique qualities you bring. Our culture encourages personal expression, open dialogue, and genuine connections, where you are valued,...
-
QC Specialist
3 days ago
Singapore MIRXES PTE. LTD. Full timeMiRXES is a Singapore-headquartered molecular diagnostic company with R&D, manufacturing, and clinical lab operations in Singapore, USA, Japan, and China. We specialize in microRNA technologies and the development, manufacturing, and provision of diagnostic test kits and clinical services. Our mission is to enable early disease detection and provide insights...
-
QC Specialist I
4 weeks ago
Singapore Novartis Full timeSummary Establish and ensure testing of drug substance release and stability testing including all testing of intermediates in process. Control samples and lab operations are in accordance with written testing SOP's and local/international regulations. About the Role Key Responsibilities: Ox/Deviation handling. CAPA definition and KPI trending - Ensure all...
-
QC Specialist I
5 days ago
Singapore Healthcare Businesswomen’s Association Full timeJob Description Summary Establish and ensure testing of drug substance release and stability testing including all testing of intermediates in process. Control samples and lab operations are in accordance with written testing SOPs and local/international regulations. Job Description Key Responsibilities OOff/Deviation handling. CAPA definition - KPI...
-
QC Specialist/ Senior QC Specialist
5 days ago
Singapore Roche Full timeOverview Join to apply for the QC Specialist/ Senior QC Specialist role at Roche . The Position A healthier future drives Roche to innovate and ensure everyone has access to healthcare today and for generations to come. As a Quality Control Analyst based in Singapore, you will join our Microbiology/Environmental Monitoring (EM) team. You will be responsible...
-
QA/qc Engineer
1 week ago
Singapore APPLIED ENGINEERING PTE LTD Full timeDuties and Responsibilities: a. Assist QA/QC Manager in the managing the QA/QC department b. Establish, implement and maintain the QC system for products that need to comply with ASME codes c. Prepare, control and maintain the QC Manual in accordance with ASME code d. Initiate quality programs and report to QA/QC Manager for the current product quality...