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1 week ago
As a Testing Specialist, you will be responsible for ensuring the quality and stability of drug substances. This includes testing intermediates in process, controlling samples and lab operations, and ensuring compliance with written testing SOPs and local/international regulations.
">Key Responsibilities- 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.
- Perform Microbiological testing of materials and utilities, environmental and personnel monitoring.
- Provide expert Support for site qualification and validation activities.
- Maintain and calibrate equipment including plan preparation.
Additionally, you will be responsible for:
- Trend analysis of KPI/KQI
- Support sample planning and sampling execution
- Distribution of marketing samples (where applicable)
- Complying with all HSE guidelines
- Reporting potential accidents, risks, and proposing solutions
You will require:
- 6+ years of professional experience 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
- Result-oriented approach
It is desirable to have technical education and 3-5 years of relevant experience or a University degree in Microbiology, Biochemistry, or equivalent plus 0-4 years of working experience.
The ideal candidate will possess the following skills:
- 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
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