Microbiologist

4 months ago

East London, South Africa Aspen Pharma Group Full time

**Overview**
- Perform microbiological tests on raw materials, water, cleaning and environmental samples, in-process and final products to ensure quality and compliance.
- Review compliance of documentation according to pharmaceutical standards

**Responsibilities**

**Planning and Operational Support**
- Optimise and facilitate implementation of current processes
- Identify gaps in current policies and procedures
- Propose changes or improvements to processes, tools and techniques

**Microbiological Testing**
- Perform microbiological tests on raw materials, in-process and final products to ensure quality and compliance with GMP standards
- Test water according to SOPs and testing schedule
- Notify Production of source of any contamination timeously
- Develop and implement plans to control level and source of contamination

**Environmental Management**
- Perform sampling and testing of external environment, according to SOPs and sampling plan / schedule

**Quality Control**
- Report OOS results and deviations immediately
- Manage frequency of testing and sampling to maintain a quality process
- Maintain good housekeeping
- Manage and coordinate the use, maintenance and calibration of testing equipment according to SOPs
- Ensure continuous compliance of laboratory with GMP standards

**Reporting and Record-Keeping**
- Document and store data according to SOPs and regulation
- Consolidate information for reports on weekly / monthly basis
- Analyse consolidated data and provide recommendations
- Compile detailed and standardised reports and consolidated documents

**Skills Required**:
**Background/experience**
- National Diploma in Microbiology, with 6+ years’ experience
- Microbiological laboratory experience

**Specific job skills**
- Advanced knowledge of microbiological testing methods
- Understanding of pharmaceutical manufacturing and corrective action programs
- Pharmaceutical standards and compliance requirements
- Ability to interpret and implement policies, processes and objectives

**Competencies**
- Interrogating Information
- Following Procedures
- Maintaining Accuracy
- Customer Awareness

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