Description
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
• Microbiologist 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

Requirements
Skills Required

Background/experience

• National Diploma in Microbiology with 6+ years experience
• Microbiological laboratory experienc

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