Job 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 Procedures

• Optimize 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.
• Line & Production processing

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+ yearsxe2x80x99 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

Aspen Pharmacare