Assistant Manager/ Sr. Executive - QC(Micro)

Role & responsibilities

• Microbiological Testing: Perform microbiological testing of raw materials, in-process materials, finished products, water, and environmental samples, including microbial limit tests, bioburden testing, endotoxin testing, and sterility testing.
• Method Validation: Assist in the validation and qualification of microbiological methods and equipment to ensure compliance with GMP standards.
• Environmental Monitoring: Conduct environmental monitoring and control of critical manufacturing areas to ensure they meet required cleanliness standards.
• Documentation and Reporting: Prepare and maintain accurate, thorough documentation of test results, investigations, and quality control procedures in accordance with regulatory requirements and SOPs.
• Investigations: Investigate and assist in troubleshooting microbial contamination events and deviations, and implement corrective actions.
• Compliance: Ensure that all testing activities comply with GMP (Good Manufacturing Practices), GLP (Good Laboratory Practices), and other relevant industry regulations.
• Equipment Maintenance: Ensure that microbiological equipment and instruments are maintained and calibrated per company procedures.
• Training: Provide training and guidance to junior team members on microbiological techniques and regulatory requirements.
• Continuous Improvement: Participate in continuous improvement projects to enhance QC procedures and processes.

Preferred candidate profile

• Education: Bachelors or Master’s degree in Microbiology, Biotechnology, Life Sciences, or a related field.
• Experience: Minimum of 7 to 10 years of experience in microbiological testing, preferably in a pharmaceutical or biotechnology environment.
• Skills:
• Proficiency in microbiological techniques and equipment (e.g., autoclaves, incubators, laminar flow hoods, etc.).
• Strong knowledge of GMP, GLP, and FDA regulations.
• Ability to interpret and analyze microbiological data.
• Familiarity with microbiological testing methods such as USP and EP compendial methods.
• Excellent attention to detail and organizational skills.
• Strong communication skills and ability to work well in a team environment.
• Certifications: Certification in microbiology or related disciplines (e.g., ASQ certification) is a plus.