POSITION SUMMARY
Key Tasks
1. Performs microbial testing of raw materials, packaging materials, intermediate, bulk, finished product, lab trial and stability samples using current pharmacopoeias and established procedures. Ensures all analysis is completed, reviewed and approved within agreed turn around times.
2. Performs routine environmental monitoring; air sampling, bio-trace swabbing of machinery and equipment, swabbing of personnel as necessary.
3. Performs other duties which may be assigned bY
Quality Manager, for which training and/or an
explanation has been provided and understood.
3.1 Finished Product inspection
3.2 Returned Goods inspection
3.3 cGMP audit
3.4 Validation activities
3.5 Quality Control Processes (Raw Material, In- Process, Packaging, Finished Goods)
3.6 In-line Inspection
4. Performs routine testing on water purification system in line with company and regulatory specifications. Trends associated data.
5. Performs microbial identification to ensure compliance with procedure and regulatory requirements.
6. Organizes and maintains standard procedures and microbial test records in an organized system for easy retrieval.
7. Maintains and coordinates calibration of measuring equipment in the area of assignment.
8. Ensures that procedures are carried out carefully, accurately, and complying with Good Laboratory Practices (GLP) and Good Microbiological
Practices to eliminate errors.
9. Ensures that Good Manufacturing practices (GMP) are being implemented in production line and in the plant premises at all times.
10. Performs quality control on incoming media and
maintains inventory of reagents. Ensures lab is supplied with consumables. Prepares request for purchase.
Education & Training:
Minimum of Bachelor’s degree in Microbiology, Biology, Chemistry, Pharmacy
Work Experience Requirements:
At least one (1) year relevant experience of micro analysis and
operation experience in a cosmetic, pharmaceutical or biotech
environment.
Skill/Knowledge & Other Requirements:
Have an understanding of techniques used in microanalysis.Has knowledge in Good Laboratory Practices and Good Manufacturing Practices.Strong computer skills.Good in oral and written communication.Have initiative, high attention to detail, and the ability to multi-task.