职位详情
国籍要求:马来西亚
职位描述
Key Responsibilities
1. Environmental & Utilities Monitoring
Perform environmental monitoring across manufacturing areas (K1–K4) in accordance with approved procedures
Conduct water sampling (PW, WFI) and monitoring of utilities including clean steam, compressed gases, and compressed dry air
Perform microbial testing including Total Plate Count, Microbial Limit Test, and Bacterial Endotoxin Test
2. Microbiological Testing & Analysis
Conduct bioburden testing, sterility testing, and microbial contamination testing for raw materials, finished goods, and stability samples
Perform identification of microbial isolates from environmental and water monitoring
Support media fill and aseptic process simulation (APS), including visual inspection and reporting
3. Laboratory Operations & Compliance
Ensure accurate data entry and reporting in LIMS system
Prepare trending reports for environmental and utilities monitoring
Review laboratory logbooks and perform instrument verification (balances, glassware)
Maintain laboratory inventory including reagents, media, and consumables
4. Documentation & Quality Compliance
Report non-conformance, deviations, and out-of-specification (OOS) results
Assist in preparation of SOPs, protocols, reports, and CAPA documentation
Ensure adherence to cGMP, GLP, GDP, and laboratory safety standards
5. Laboratory Support Activities
Support media preparation, growth promotion testing, and biological indicator testing
Assist in waste management and laboratory decontamination processes
Participate in cross-functional study activities and validation-related testing
Requirements
Qualifications
Bachelor’s Degree in Microbiology, Biotechnology, Biochemistry, or related field
Fresh graduates are welcome to apply
Experience
Good to have at least 1 year of experience in pharmaceutical or laboratory environment
Experience in microbiological testing and aseptic techniques is preferred
Technical Skills & Knowledge
Knowledge of cGMP, GLP, and GDP requirements
Hands-on experience in microbiological testing and environmental monitoring
Familiarity with LIMS systems and laboratory documentation
Strong understanding of aseptic techniques and contamination control
Good analytical and problem-solving skills
Competencies
Detail-oriented with strong compliance mindset
Good teamwork and communication skills
Ability to manage tasks efficiently and meet deadlines
Proactive and accountable in laboratory operations