Key Responsibilities
- Microbiological Testing and Analysis
- Conduct microbiological testing of food, water, Tea, AYUSH products, and other samples as per ISO 17025:2017 scope of accreditation.
- Perform tests for microbial contamination, pathogen detection (e.g., Salmonella, E. coli, Listeria, Shigella, Vibrio spp. etc.), spoilage organisms, and shelf-life studies.
- Interpret and validate test results, ensuring accuracy and compliance with regulatory standards.
- Perform tests for microbial contamination, pathogen detection (e.g., Salmonella, E. coli, Listeria, Shigella, Vibrio spp. etc.), spoilage organisms, and shelf-life studies.
- Interpret and validate test results, ensuring accuracy and compliance with regulatory standards.
- Conduct microbiological testing of food, water, Tea, AYUSH products, and other samples as per ISO 17025:2017 scope of accreditation.
- Perform tests for microbial contamination, pathogen detection (e.g., Salmonella, E. coli, Listeria, Shigella, Vibrio spp. etc.), spoilage organisms, and shelf-life studies.
- Interpret and validate test results, ensuring accuracy and compliance with regulatory standards.
- Quality Assurance and Compliance
- Ensure all testing procedures adhere to ISO 17025 accreditation requirements and other regulatory standards (NABL, EIC, APEDA, FSSAI, Tea Board, AYUSH).
- Maintain and update Standard Operating Procedures (SOPs) for microbiological department.
- Perform internal audits, proficiency testing, and inter-laboratory comparisons to uphold accreditation standards.
- Implement corrective and preventive actions (CAPA) based on audit findings or non-conformities.
- Maintain and update Standard Operating Procedures (SOPs) for microbiological department.
- Perform internal audits, proficiency testing, and inter-laboratory comparisons to uphold accreditation standards.
- Implement corrective and preventive actions (CAPA) based on audit findings or non-conformities.
- Ensure all testing procedures adhere to ISO 17025 accreditation requirements and other regulatory standards (NABL, EIC, APEDA, FSSAI, Tea Board, AYUSH).
- Maintain and update Standard Operating Procedures (SOPs) for microbiological department.
- Perform internal audits, proficiency testing, and inter-laboratory comparisons to uphold accreditation standards.
- Implement corrective and preventive actions (CAPA) based on audit findings or non-conformities.
- Laboratory Management
- Oversee daily operations of the microbiology laboratory, including equipment maintenance, calibration, and inventory management, sample management, sampling at customer sites and other relevant tasks in order to ensure the validity of test results.
- Ensure proper handling, storage, and disposal of biohazardous materials in compliance with safety regulations.
- Monitor laboratory performance, such as turnaround time and test accuracy.
- Coordinate with external auditors and regulatory bodies during assessment.
- Establish and document measurement uncertainty for microbiological test results in accordance with ISO 17025 requirements.
- Identify sources of uncertainty in testing processes and implement strategies to minimize variability.
- Maintain records of uncertainty evaluations and provide training to staff on uncertainty measurement principles.
- Perform method verification to ensure that standard methods (e.g., ISO, FSSAI, APHA or AOAC) are suitable for the laboratory’s equipment, personnel, and testing scope.
- Conduct method validation for new or modified microbiological test methods, including determination of accuracy, precision, specificity, and limits of detection.
- Document verification and validation studies, ensuring compliance with NABL and ISO 17025 standards.
- Periodically review and update validated methods to maintain their suitability and reliability.
- Maintain and manage microbial cultures, including reference strains and working cultures, ensuring viability and purity.
- Perform regular sub-culturing, preservation, and documentation of microbial cultures as per the SOP.
- Ensure proper storage conditions (e.g., cryopreservation) and compliance with biosafety guidelines.
- Verify culture identity and performance for use in quality control and testing procedures.
- Ensure proper handling, storage, and disposal of biohazardous materials in compliance with safety regulations.
- Monitor laboratory performance, such as turnaround time and test accuracy.
- Coordinate with external auditors and regulatory bodies during assessment.
- Establish and document measurement uncertainty for microbiological test results in accordance with ISO 17025 requirements.
- Identify sources of uncertainty in testing processes and implement strategies to minimize variability.
- Maintain records of uncertainty evaluations and provide training to staff on uncertainty measurement principles.
- Perform method verification to ensure that standard methods (e.g., ISO, FSSAI, APHA or AOAC) are suitable for the laboratory’s equipment, personnel, and testing scope.
- Conduct method validation for new or modified microbiological test methods, including determination of accuracy, precision, specificity, and limits of detection.
- Document verification and validation studies, ensuring compliance with NABL and ISO 17025 standards.
- Periodically review and update validated methods to maintain their suitability and reliability.
- Maintain and manage microbial cultures, including reference strains and working cultures, ensuring viability and purity.
- Perform regular sub-culturing, preservation, and documentation of microbial cultures as per the SOP.
- Ensure proper storage conditions (e.g., cryopreservation) and compliance with biosafety guidelines.
- Verify culture identity and performance for use in quality control and testing procedures.
- Oversee daily operations of the microbiology laboratory, including equipment maintenance, calibration, and inventory management, sample management, sampling at customer sites and other relevant tasks in order to ensure the validity of test results.
- Ensure proper handling, storage, and disposal of biohazardous materials in compliance with safety regulations.
- Monitor laboratory performance, such as turnaround time and test accuracy.
- Coordinate with external auditors and regulatory bodies during assessment.
- Establish and document measurement uncertainty for microbiological test results in accordance with ISO 17025 requirements.
- Identify sources of uncertainty in testing processes and implement strategies to minimize variability.
- Maintain records of uncertainty evaluations and provide training to staff on uncertainty measurement principles.
- Perform method verification to ensure that standard methods (e.g., ISO, FSSAI, APHA or AOAC) are suitable for the laboratory’s equipment, personnel, and testing scope.
- Conduct method validation for new or modified microbiological test methods, including determination of accuracy, precision, specificity, and limits of detection.
- Document verification and validation studies, ensuring compliance with NABL and ISO 17025 standards.
- Periodically review and update validated methods to maintain their suitability and reliability.
- Maintain and manage microbial cultures, including reference strains and working cultures, ensuring viability and purity.
- Perform regular sub-culturing, preservation, and documentation of microbial cultures as per the SOP.
- Ensure proper storage conditions (e.g., cryopreservation) and compliance with biosafety guidelines.
- Verify culture identity and performance for use in quality control and testing procedures.
- Team Leadership and Training
- Supervise and mentor Junior microbiologists, lab technicians, and support staff.
- Develop comprehensive training plans for laboratory staff, covering microbiological techniques, measurement of uncertainty, method verification/validation, culture maintenance, safety protocols, and regulatory compliance.
- Execute training programs through hands-on sessions, workshops, and assessments to ensure staff competency.
- Evaluate training effectiveness and update plans based on feedback and evolving laboratory needs.
- Maintain training records in compliance with ISO 17025 and NABL requirements.
- Foster a culture of continuous improvement and adherence to Good Laboratory Practices (GLP) and ensure implementation of complete 5S in the microbiology lab.
- Develop comprehensive training plans for laboratory staff, covering microbiological techniques, measurement of uncertainty, method verification/validation, culture maintenance, safety protocols, and regulatory compliance.
- Execute training programs through hands-on sessions, workshops, and assessments to ensure staff competency.
- Evaluate training effectiveness and update plans based on feedback and evolving laboratory needs.
- Maintain training records in compliance with ISO 17025 and NABL requirements.
- Foster a culture of continuous improvement and adherence to Good Laboratory Practices (GLP) and ensure implementation of complete 5S in the microbiology lab.
- Supervise and mentor Junior microbiologists, lab technicians, and support staff.
- Develop comprehensive training plans for laboratory staff, covering microbiological techniques, measurement of uncertainty, method verification/validation, culture maintenance, safety protocols, and regulatory compliance.
- Execute training programs through hands-on sessions, workshops, and assessments to ensure staff competency.
- Evaluate training effectiveness and update plans based on feedback and evolving laboratory needs.
- Maintain training records in compliance with ISO 17025 and NABL requirements.
- Foster a culture of continuous improvement and adherence to Good Laboratory Practices (GLP) and ensure implementation of complete 5S in the microbiology lab.
- Data Management and Reporting
- Prepare detailed technical documents including raw data, logbooks etc and documentation for regulatory submissions like MoU, method verification and method validation.
- Maintain accurate records of test results, quality control data, and laboratory activities in compliance with ISO 17025.
- Communicate findings and recommendations to the Senior Manager and relevant authority.
- Maintain accurate records of test results, quality control data, and laboratory activities in compliance with ISO 17025.
- Communicate findings and recommendations to the Senior Manager and relevant authority.
- Prepare detailed technical documents including raw data, logbooks etc and documentation for regulatory submissions like MoU, method verification and method validation.
- Maintain accurate records of test results, quality control data, and laboratory activities in compliance with ISO 17025.
- Communicate findings and recommendations to the Senior Manager and relevant authority.
- Research and Development
- Stay updated on advancements in microbiological testing methods and regulatory requirements.
- Develop and validate new testing methods to expand the laboratory’s scope of accreditation.
- Collaborate with cross-functional teams to support product development and regulatory compliance for clients.
- Develop and validate new testing methods to expand the laboratory’s scope of accreditation.
- Collaborate with cross-functional teams to support product development and regulatory compliance for clients.
- Stay updated on advancements in microbiological testing methods and regulatory requirements.
- Develop and validate new testing methods to expand the laboratory’s scope of accreditation.
- Collaborate with cross-functional teams to support product development and regulatory compliance for clients.
Qualifications and Skills
- Education: Master’s degree or Ph.D. in Microbiology, Biotechnology, or a related field.
- Experience:
- Minimum 4–6 years of experience in a microbiology laboratory, preferably in an ISO 17025 accredited facility.
- Should have exposure and experience of NABL, EIC, APEDA, FSSAI, Tea Board, or AYUSH assessment.
- Prior supervisory or team lead experience is highly desirable.
- Minimum 4–6 years of experience in a microbiology laboratory, preferably in an ISO 17025 accredited facility.
- Should have exposure and experience of NABL, EIC, APEDA, FSSAI, Tea Board, or AYUSH assessment.
- Prior supervisory or team lead experience is highly desirable.
- Technical Skills:
- Proficiency in microbiological techniques (e.g., culture, enumeration, pathogen detection, molecular methods like PCR, ELISA).
- Familiarity with laboratory equipment such as autoclaves, incubators, biosafety cabinets, and PCR machines.
- Knowledge of ISO 17025 standards, GLP, and quality management systems. GDP, 5S.
- Proficiency in microbiological techniques (e.g., culture, enumeration, pathogen detection, molecular methods like PCR, ELISA).
- Familiarity with laboratory equipment such as autoclaves, incubators, biosafety cabinets, and PCR machines.
- Knowledge of ISO 17025 standards, GLP, and quality management systems. GDP, 5S.
- Soft Skills:
- Strong analytical and problem-solving skills.
- Excellent communication and interpersonal skills for team management and client interactions.
- Detail-oriented with a commitment to accuracy and compliance.
- Strong analytical and problem-solving skills.
- Excellent communication and interpersonal skills for team management and client interactions.
- Detail-oriented with a commitment to accuracy and compliance.
- Certifications: Training or certification in ISO 17025:2017 or NABL authorized signatory is a plus.
- Education: Master’s degree or Ph.D. in Microbiology, Biotechnology, or a related field.
- Experience:
- Minimum 4–6 years of experience in a microbiology laboratory, preferably in an ISO 17025 accredited facility.
- Should have exposure and experience of NABL, EIC, APEDA, FSSAI, Tea Board, or AYUSH assessment.
- Prior supervisory or team lead experience is highly desirable.
- Technical Skills:
- Proficiency in microbiological techniques (e.g., culture, enumeration, pathogen detection, molecular methods like PCR, ELISA).
- Familiarity with laboratory equipment such as autoclaves, incubators, biosafety cabinets, and PCR machines.
- Knowledge of ISO 17025 standards, GLP, and quality management systems. GDP, 5S.
- Soft Skills:
- Strong analytical and problem-solving skills.
- Excellent communication and interpersonal skills for team management and client interactions.
- Detail-oriented with a commitment to accuracy and compliance.
- Certifications: Training or certification in ISO 17025:2017 or NABL authorized signatory is a plus.
Key Competencies
- Leadership and team management.
- Regulatory compliance and quality assurance.
- Time management and ability to handle multiple priorities.
- Commitment to maintaining a safe and compliant laboratory environment.
Work Environment
- The role involves working in a laboratory setting with potential exposure to biohazardous materials.
- Strict adherence to safety protocols and use of personal protective equipment (PPE) is required.
- Occasional overtime or weekend work may be necessary to meet project deadlines.
Reporting Structure
- The Senior Microbiologist will report directly to the Senior Manager, Microbiology Laboratory.
- Collaborate with other departments, including quality control, R&D, and regulatory affairs.