Pharmaceutical Microbiologist Specialist
3 weeks ago
The position of Microbiologist at Nalis Pharmaceuticals is available. This role involves ensuring the quality and safety of our pharmaceutical products through the detection of microbial contamination and compliance with established specifications.
Key Responsibilities:
• Conducting microbiological tests on raw materials and finished products to detect microbial contamination and ensure compliance with established specifications.
• Developing, validating, and optimizing microbiological testing methods in accordance with regulatory requirements (e.g., FDA, EMA).
• Analyzing test results and interpreting data to provide insights on microbial quality and safety, preparing comprehensive reports for internal and external stakeholders.
• Investigating sources of microbial contamination and developing strategies for contamination control to improve manufacturing processes and product quality.
• Collaborating with the Quality Assurance team to ensure that microbiological testing aligns with Good Manufacturing Practices (GMP) and other regulatory standards.
• Participating in research and development projects aimed at improving product formulations and enhancing microbial stability.
• Providing training and guidance to laboratory personnel on microbiological techniques, safety protocols, and best practices.
• Maintaining accurate and detailed records of all testing activities, procedures, and results in compliance with laboratory protocols and regulatory requirements.
• Staying current with industry trends, advancements in microbiology, and regulatory changes to contribute to the continuous improvement of laboratory processes and procedures.
Qualifications:
• A Bachelor’s degree in Microbiology, Biology, or a related field (Master’s degree preferred).
• A minimum of 2 years of experience in microbiological testing, preferably in a pharmaceutical or biotechnology setting.
• A strong understanding of microbiological techniques, aseptic practices, and regulatory requirements governing microbiological testing.
• Excellent analytical and problem-solving skills, attention to detail, and proficiency in laboratory software and data analysis tools.
Working Conditions:
• Ability to work in a laboratory environment, including the ability to lift and carry materials and stand for extended periods.
• May involve working in cleanroom environments and adherence to strict safety and contamination control protocols.
Physical Requirements:
• Ability to work in a fast-paced environment and meet deadlines while maintaining attention to detail and quality standards.
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