Manager

Job summary
The Quality Control Microbiology Manager will coordinate and lead all activities to ensure the timely testing and release of all resultsLead a group of lab associates and represent QC leadershipDeliver quality products and services on time to all customers
Job seniority: mid-to-senior level
Responsibilities
• Coordinate and lead activities related to QC Microbiology department• Ensure timely testing and release of results• Governance responsibilities for various microbial testing processes• Lead a group of lab associates• Provide training opportunities and resources to meet customer requirements• Monitor processes and products for continuous improvement• Serve as subject matter expert on specific areas and techniques• Be a primary point of contact for communication to Senior Management• Assist in investigations and CAPA implementation• Ensure lab readiness and maintain GMP and GLP systems and environment
Requirements
• Bachelor's degree in Microbiology or related science• At least 5 years' experience in pharmaceutical/Biotechnology industries conducting QC Microbiology testing• Minimum of 2 years' previous leadership/management experience• SME level knowledge of Microbiology and aseptic manufacturing
Key Skills Needed
• Experience in culturing microbes and classical microbiology techniques• Experience in data/statistical analysis and reporting results• Understanding of cGMP/GLP regulations• Familiarity with relevant FDA, EMA, ICH, USP and EP guidelines