
Qc Specialist I
13 hours ago
**Summary**:
- Highly skilled and experienced laboratory professional who contributes by performing analytical release testing, investigational support, research support, and stability testing
**About the Role**:
**QC Specialist I (Raw Materials)**
**Location - Singapore**
**About the Role**:
To support all activities in QC Raw Materials laboratory in accordance with written testing SOP’s and local/ international regulations which contributes by performing testing, maintenance, calibration and qualification of analytical equipment. To plan day to day laboratory operation and lead change initiatives and laboratory investigation.
**Key Responsibilities**:
- OOx/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)
- Maintain and calibrate equipment incl. plan preparation
- Support in supplier qualification
- Trending and analysis of KPI/KQI
- Support sample planning and sampling execution
- Stability (when not centralized)
- 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)
**Role Requirements**:
**Essential Requirements**:
- Professional experience (3-5 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
- Laboratory equipment; Quality Control (QC) Testing; Quality Control Sampling; Knowledge of TQM and related industry GxP standards and processes; Laboratory Excellence; Quality decision making
**Desirable Requirements**:
- Technical education & 3-5 years relevant experience or
- University degree in Pharmacy or Chemistry or equivalent + 0-4 years working experience
Division
Operations
Business Unit
Innovative Medicines
Location
Singapore
Site
Tuas South Avenue
Company / Legal Entity
SG12 (FCRS = SG012) Novartis Singapore Pharmaceutical Manufacturing Pte Ltd
Functional Area
Quality
Job Type
Full time
Employment Type
Regular
Shift Work
No
Novartis is committed to building an outstanding, inclusive work environment and diverse teams' representative of the patients and communities we serve.
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