On Q Recruitment is proud to exclusively partner with Viral Vector Manufacturing Facility (VVMF) to build their quality function. As VVMF establishes a world-class facility to deliver advanced viral vector manufacturing solutions for the biopharmaceutical industry, they are seeking a Microbiological Specialist to join their growing team.
About the Role: Reporting to the Quality Control Manager, this newly created role will support the Quality Control (QC) Department with microbiological compliance activities, including daily operations, microbiological testing, and monitoring activities to ensure compliance with Good Manufacturing Practices (GMP) and regulatory standards.
Key Responsibilities: Perform microbiological testing for sterility, endotoxin, bioburden, microbial limits, and environmental monitoring.Conduct testing for process, cleaning, raw materials, stability samples, and water samples.Ensure analytical methods are qualified, validated, and maintained per regulatory requirements.Support analytical method verification, transfer, and validation as needed.Analyse QC data trends, identify potential issues, and propose performance improvements.Investigate and document deviations, out-of-specifications (OOS), and out-of-trend (OOT) results, ensuring timely resolution.Participate in supplier management processes to ensure material compliance for pharmaceutical manufacturing.Coordinate and support the facility's environmental monitoring program, including air, surfaces, water, and personnel.Prepare and review data for reports, investigations, KPIs, and quality metrics.Engage with stakeholders to address microbiological queries and build strong internal and external relationships.Qualifications and Skills: A degree in Microbiology, Biotechnology, or a related field.At least 2 years of microbiology experience within the pharmaceutical industry.Experience in sterile environments is desirable.Proficiency in microbial testing, environmental monitoring, and contamination control strategies.Knowledge of TGA and other regulatory requirements for sterile manufacturing.Strong problem-solving, analytical, and communication skills.This is a rare opportunity to join an innovative organisation at a pivotal time and help build the foundation for its success. For a confidential conversation, please email Grace Bitodi at ******.
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