Job Overview

The Microbiological Analyst at Jawa International Limited is responsible for performing microbiological tests and analysis on pharmaceutical products, raw materials, and the manufacturing environment to ensure they meet specified standards of quality, sterility, and safety. This role is crucial in ensuring that all products comply with regulatory requirements, including Good Manufacturing Practices (GMP), and are safe for consumer use.

The Microbiological Analyst conducts testing of pharmaceutical products to detect microbial contamination, monitors environmental controls, and maintains accurate records of laboratory findings to ensure the safety and efficacy of all products.

Key Responsibilities

• Perform microbiological analysis of raw materials, in-process samples, finished products, and water systems to detect and quantify microorganisms such as bacteria, fungi, and yeast in line with GMP, pharmacopeia standards, and regulatory guidelines from agencies such as NAFDAC.
• Perform environmental monitoring of the cleanrooms and production areas, including air sampling, surface sampling, and personnel monitoring to ensure compliance with GMP standards.
• Perform bioburden testing, endotoxin testing, and preservative efficacy testing on pharmaceutical products.
• Ensure the proper use and maintenance of microbiological media, reagents, and laboratory equipment.
• Conduct environmental monitoring of production areas, including air quality, surface swabs, and water samples, to ensure cleanroom conditions meet required standards.
• Analyze trends in environmental monitoring data and report any out-of-specification results or deviations.
• Maintain accurate records of all microbiological tests performed, including raw data, test results, and laboratory observations.
• Prepare microbiological test reports and certificates of analysis (COA) for all batches tested, ensuring compliance with regulatory and internal requirements.
• Assist in reviewing and updating Standard Operating Procedures (SOPs) related to microbiological testing and laboratory operations.
• Participate in internal and external audits by providing microbiological data and documentation to demonstrate compliance with regulatory requirements.
• Ensure proper handling and disposal of hazardous waste and maintain a safe working environment according to laboratory safety guidelines.
• Calibrate and maintain microbiological testing equipment, including autoclaves, incubators, and laminar flow hoods, to ensure accurate and reliable test results, and report any equipment malfunctions or laboratory incidents and arrange for necessary repairs or replacements.
• Assist in validating and qualifying microbiological testing methods, including sterility and bioburden tests.
• Support product development and manufacturing teams by providing microbiological data and input during the product development process.
• Investigate microbiological test failures, deviations, and out-of-specification results, and collaborate with relevant departments to implement corrective and preventive actions (CAPA). Also, contribute to root cause analysis and participate in efforts to improve laboratory procedures and product quality continuously.

Qualifications

Education

B.Sc./HND Microbiology.

Experience

Experienced or inexperienced candidates with sound knowledge of key concepts will be considered.

Skills and Competencies

• Proficiency in microbiological techniques and the use of laboratory equipment (e.g., autoclaves, incubators, microscopes).
• Strong analytical and problem-solving skills with a keen attention to detail.
• Excellent documentation and record-keeping skills.
• Ability to work independently and as part of a team.
• Strong communication skills and the ability to collaborate with cross-functional teams.