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2 days ago
The Quality Assurance Microbiologist plays a crucial role in ensuring the microbiological quality of pharmaceutical products. This position involves performing routine microbiological tests and analyses, monitoring environmental conditions, and maintaining adherence to Good Manufacturing Practices (GMP) and regulatory requirements.
Main Responsibilities- Microbiological Testing: Conduct microbiological testing on raw materials, in-process materials, and finished products. Perform tests such as sterility testing, endotoxin testing, LAL, bioburden testing, and microbial limit testing. Analyze results 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 required microbiological standards.
- Microbial Identification: Identify microorganisms through techniques like gram staining, biochemical testing, PCR, or other molecular methods.
- Validation and Compliance: Participate in microbiological method validation, equipment qualification, and requalification processes. Ensure all microbiological testing complies with current cGMP and applicable regulatory standards.
- Education: Bachelor's degree in Microbiology, Biotechnology, or a related field. A Master's degree or relevant certifications in microbiology are desirable.
- Experience: Minimum 2-4 years of experience in microbiological testing and quality control in a pharmaceutical or related industry.
- Technical Skills: Proficient in microbiological techniques like microbial identification, sterility testing, endotoxin testing, and microbial limit tests.
- Regulatory Knowledge: Understanding of cGMP, GLP, and regulatory requirements like FDA, USP, and ICH guidelines.
- Soft Skills: Strong attention to detail, excellent problem-solving skills, good communication, and team collaboration skills.
This is an exciting opportunity for a motivated and detail-oriented Quality Assurance Microbiologist to join our team. The successful candidate will have the opportunity to work in a dynamic and fast-paced environment, contributing to the development and implementation of microbiological testing programs.
Benefits- A competitive salary and benefits package
- Opportunities for professional growth and development
- A collaborative and supportive work environment
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