Description 

• We are seeking a skilled and experienced Microbiologist to join our Quality Control team at our pharmaceutical factory. The Microbiologist will be responsible for performing microbiological testing and analysis of raw materials, in-process samples, and finished products to ensure compliance with regulatory requirements and quality standards.

Key Responsibilities

• Microbiological Testing:

  • Perform routine and non-routine microbiological testing of raw materials, in-process samples, and finished products using standard microbiological techniques and procedures.
  • Conduct microbial enumeration, identification, and antimicrobial effectiveness testing to assess the microbial quality of pharmaceutical products.

• Environmental Monitoring:

  • Conduct environmental monitoring of cleanrooms, manufacturing areas, and utilities to assess microbial contamination levels and ensure compliance with Good Manufacturing Practices (GMP).

• Method Development and Validation:

  • Develop and validate microbiological test methods in accordance with regulatory requirements and industry standards.
  • Optimize test methods to improve sensitivity, accuracy, and efficiency while ensuring reproducibility and reliability of results.

• Documentation and Record Keeping:

  • Maintain accurate and detailed records of all microbiological testing activities, including test results, observations, and data analysis.
  • Prepare and review technical reports, protocols, and standard operating procedures (SOPs) related to microbiological testing and analysis.

• Quality Control and Compliance:

  • Ensure compliance with regulatory requirements from agencies such as the FDA, EMA, and USP.
  • Participate in internal and external audits, inspections, and regulatory submissions as needed.
  • Investigate and resolve deviations, out-of-specification results, and quality-related issues through effective root cause analysis and corrective actions.

• Continuous Improvement:

  • Identify opportunities for process improvements and efficiency gains in microbiological testing and analysis.
  • Implement best practices and innovative techniques to enhance the quality and efficiency of microbiological operations.

Requirements

• Interested candidates should possess a Bachelor’s Degree in relevant fields.