Kadispark Consult Limited is a professional consulting firm specializing in Human Resource Management, Corporate Training, Business Advisory, and Organizational Development services. The company is committed to helping businesses improve workforce productivity, strengthen organizational performance, and achieve sustainable growth through innovative people-management solutions.
Our services include recruitment and talent acquisition, performance management, employee training and development, strategic human resource management, organizational restructuring, policy development, business registration support, corporate compliance advisory, and management consulting. Kadispark also provides professional capacity-building programs in Project Management Professional (PMP), Health, Safety and Environment (HSE), Strategic Human Resource Management (SHRM), leadership development, and workplace effectiveness, equipping individuals and organizations with the skills required to compete in today's dynamic business environment.
Job Summary
- The Microbiologist is responsible for performing microbiological testing of raw materials, water systems, environmental samples, in-process materials, and finished pharmaceutical products to ensure compliance with cGMP, regulatory requirements, and company quality standards.
- The role supports contamination control, environmental monitoring, and microbiological investigations within the manufacturing facility.
Key Responsibilities
Microbiological Testing:
- Perform microbiological analysis of raw materials, finished products, and packaging materials.
- Conduct microbial limit tests, bioburden testing, and sterility testing according to approved procedures.
- Perform tests for specified microorganisms and objectionable organisms.
- Carry out endotoxin testing using approved methods.
- Prepare, sterilize, and maintain microbiological media and reagents.
- Perform microbial identification using conventional and rapid identification techniques.
Environmental Monitoring:
- Conduct environmental monitoring of manufacturing areas, cleanrooms, and controlled environments.
- Perform viable and non-viable particle monitoring.
- Collect air, surface, and personnel monitoring samples.
- Trend and analyze environmental monitoring data.
- Support contamination control programs and cleanroom qualification activities.
Water System Monitoring:
- Perform microbiological testing of purified water, water for injection (WFI), and other pharmaceutical water systems.
- Monitor microbial contamination levels and investigate excursions.
- Support water system validation and routine monitoring activities.
Documentation & Compliance:
- Maintain accurate laboratory records, worksheets, logbooks, and electronic data.
- Prepare microbiological reports and Certificates of Analysis (COA), where applicable.
- Ensure compliance with Standard Operating Procedures (SOPs), Good Laboratory Practices (GLP), and current Good Manufacturing Practices (cGMP).
- Participate in internal audits, customer audits, and regulatory inspections.
Investigations & CAPA;
- Investigate Out-of-Specification (OOS), Out-of-Trend (OOT), environmental monitoring excursions, and contamination events.
- Perform root cause analysis and support implementation of Corrective and Preventive Actions (CAPA).
- Participate in deviation, change control, and risk assessment activities.
Validation & Qualification
- Support validation of sterilization processes, cleaning procedures, and aseptic manufacturing operations.
- Participate in media fill studies and aseptic process simulations.
- Assist with method validation, verification, and transfer activities.
- Support equipment, facility, and utility qualification programs.
Key Performance Indicators (KPIs)
- Timely completion of microbiological testing.
- Compliance with cGMP and data integrity requirements.
- Environmental monitoring compliance rates.
- Timely investigation and closure of microbiological deviations.
- Accuracy and reliability of laboratory results.
- Audit and inspection readiness.
Qualifications
Education:
- Bachelor's Degree in Microbiology, Applied Microbiology, Biological Sciences, Biotechnology, Biochemistry, or a related field.
Experience;
- 1–5 years of experience in a pharmaceutical microbiology laboratory.
- Experience in sterile and/or non-sterile pharmaceutical manufacturing environments preferred.
- Familiarity with regulatory guidelines and pharmacopeial requirements.
Knowledge Requirements:
- Understanding of microbiological techniques and aseptic practices.
- Knowledge of cleanroom classifications and environmental monitoring.
- Familiarity with:
- United States Pharmacopeia (USP)
- British Pharmacopoeia (BP)
- European Pharmacopoeia (Ph. Eur.)
- World Health Organization GMP guidelines
Required Skills:
- Strong microbiological laboratory skills.
- Experience with sterility testing, microbial limits testing, and environmental monitoring.
- Knowledge of contamination control and aseptic techniques.
- Strong analytical and troubleshooting abilities.
- Excellent documentation and report-writing skills.
- Attention to detail and commitment to quality.
- Ability to work independently and collaboratively within a multidisciplinary team.