Microbiology Analyst

Job Scope

Carry out microbiological analysis of samples taken from raw materials, semi-finished and finished products, raw/purified water used in the plant, plant environment, air, surfaces and employees, prepare culture media, ensure proper documentation of all activities, calculations and results according to SOPs and approved forms maintaining compliance with cGMP and GLP.

Job Requirements

Education

BSc. Degree in Microbiology, Biology, Biotechnology, Medical Analysis or related fields.

Experience

0 – 3 years of relevant experience.

Language

Proficiency in written, read and spoken Arabic and English.

Professional Knowledge

• GMP, GLP, WHO, MOH, FDA, EU Regulations
• ISPE, ICH Guidelines, USP, BB, EP and ISO Requirements
• Knowledge of Testing and Analysis Methods and Techniques
• The Ability to Validate and Revalidate Analysis Methods

Duties and Responsibilities (But not limited to)

GMP Compliance & Monitoring:

• Adhere to current Good Manufacturing Practices (cGMP) in all activities.
• Perform microbial limit testing for finished products, raw materials, compressed air, and environmental monitoring for microbiology labs, production areas, and sampling rooms.
• Ensure compliance with zoning classifications for environment monitoring.

Microbial Testing & Monitoring:

• Conduct microbial tests on production machines, surfaces, water systems, and compressed air, including personal hygiene tests for employees.
• Handle microbial testing for primary packaging materials, intermediate containers.
• Participate in media preparation, sterilization of reagents, solutions, tools, and glassware.

Instruments & Calibration:

• Monitor temperature of microbiology lab instruments (e.g., ovens, water baths).
• Perform and follow up on instrument calibrations as per approved SOPs.
• Conduct QC tests for lab instruments, including biological indicators and other routine tests.

Data Management & Reporting:

• Record and document all test activities in logbooks and approved records to ensure traceability.
• Report and document test results accurately and on time using approved formats.

Investigations & CAPAs:

• Carry out of Specification (OOS) investigations and follow up reports.
• Assist in handling deviations, investigations, and CAPAs related to microbiological input.

Housekeeping & Waste Management:

• Maintain cleanliness of microbiology labs and ensure proper housekeeping practices.
• Decontaminate biohazardous waste and dispose of all waste products per approved SOPs.

Special Projects & Additional Tasks:

• Assist in environmental monitoring for plants, risk assessment studies, and EMPQ requirements for all production lines.
• Participate in media fill simulations, incubation, and cross-contamination tests.
• Ensure the proper documentation traceability and implementation of data in the ERP system.