QC Microbiologist

Position Title: QC Microbiologist
Department: Quality Control
Location: Pharmaceutical Production Unit
Reports To: Quality Control Manager / Microbiology Supervisor

Job Summary: The QC Microbiologist is responsible for ensuring the microbiological quality of pharmaceutical products by performing routine microbiological tests and analyses, monitoring environmental conditions, and maintaining adherence to GMP (Good Manufacturing Practices) and regulatory requirements. The role involves identifying, isolating, and characterizing microorganisms, performing microbiological validation, and implementing corrective actions when necessary.

Key Responsibilities:

• Microbiological Testing and Analysis:
• Perform microbiological testing on raw materials, in-process materials, and finished products.
• Conduct tests such as sterility testing, endotoxin testing (LAL), bioburden testing, and microbial limit testing.
• Analyze results of microbiological testing and provide accurate reports.
• Environmental Monitoring:
• Monitor and assess microbiological quality in the production environment, including air, water, surfaces, and personnel.
• Ensure that cleanroom and controlled environments meet the required microbiological standards.
• Implement regular environmental monitoring programs and provide documentation of results.
• Microbial Identification and Investigation:
• Identify microorganisms through various techniques such as gram staining, biochemical testing, PCR, or other molecular methods.
• Investigate and report microbiological out-of-specification (OOS) results and deviations, and provide recommendations for corrective actions.
• Validation and Compliance:
• Participate in microbiological method validation, equipment qualification, and requalification processes.
• Ensure all microbiological testing complies with current cGMP (current Good Manufacturing Practices) and FDA, WHO, or other applicable regulatory standards.
• Maintain accurate and up-to-date records of all microbiological tests and results.
• Documentation and Reporting:
• Prepare and review laboratory reports, testing protocols, and batch records for accuracy and compliance.
• Ensure the timely completion of documentation for microbiological testing in accordance with standard operating procedures (SOPs).
• Training and Support:
• Provide microbiological expertise and training to production staff, ensuring the proper implementation of microbiological best practices.
• Support troubleshooting of microbiological issues related to production processes.
• Equipment and Inventory Management:
• Ensure calibration and maintenance of microbiological testing equipment.
• Maintain an inventory of microbiological reagents, culture media, and other supplies, ensuring stock levels are adequate for testing needs.
• Continuous Improvement:
• Collaborate with cross-functional teams to improve microbiological processes, enhance testing methods, and optimize laboratory workflows.
• Participate in audits and inspections, and contribute to CAPA (Corrective and Preventive Action) processes as necessary.

Skills and Qualifications:

• Education:
• Bachelor’s degree in Microbiology, Biotechnology, or a related field. A Master's degree or relevant certifications in microbiology is a plus.
• Experience:

Minimum of 2-4years of experience in microbiological testing and quality control in a pharmaceutical or related industry.

• Technical Skills:
• Proficient in microbiological techniques such as microbial identification, sterility testing, endotoxin testing, and microbial limit tests.
• Familiar with laboratory equipment and instruments used in microbiological testing (e.g., incubators, autoclaves, laminar flow hoods, etc.).
• Knowledge of microbiological safety and laboratory hygiene protocols.
• Regulatory Knowledge:
• Understanding of cGMP, GLP, and regulatory requirements such as FDA, USP, and ICH guidelines.
• Familiarity with pharmaceutical industry standards and laboratory best practices.
• Soft Skills:
• Strong attention to detail and accuracy in testing and documentation.
• Excellent problem-solving skills and the ability to perform investigative work.
• Good communication and team collaboration skills.
• Certifications:
• Certification in microbiology or related fields is desirable (e.g., ASQ, PMP).

Job Type: Full-time

Pay: ₹20,000.00 - ₹30,000.00 per month

Benefits:

• Cell phone reimbursement
• Internet reimbursement
• Leave encashment

Experience:

• QC, Microbiologist: 3 years (Required)

Work Location: In person