Job Summary Reporting to the Microbiology Lead, this role will provide online QC oversight to Drug Substance/ Drug Product manufacturing operations in WuXi Vaccines.
This is a crucial role within the Quality organisation with responsibility for directly supporting the manufacturing operations team on a daily basis, ensuring compliance with cGMP and corporate and local SOPs.
This position will initially operate standard office hours Monday-Friday but will transition to a 4 Cycle shift pattern to support routine site operations, specifically Environmental Monitoring and Clean Utility sampling and testing.
Key Responsibilities: Provide QC support to technology transfer and commercial manufacturing operations Perform QC review of SOPs, risk assessments, change controls and other documentation, as applicable, associated with DS/DP manufacturing operations Participate on microbiology projects, including microbial method validation and testing, environmental monitoring, microbial organism identification, supporting facility qualification, cleaning validation, and process validation Perform microbial testing and participate with atypical/OOS investigations, change controls, and CAPAs Work with supervisors and other team members to review and monitor method performance Author of technical documents including methods protocols, qualification / validation protocols and reports, SOPs, etc.
Provide technical guidance, as well as evaluate / introduce new technologies in microbiology area Assist Microbiology Lead to develop micro control strategies, quality enhancement, and operational efficiency improvement Provide effective communication and play a leading role in project management interaction with internal and external clients such as Quality Assurance, Regulatory Affairs, and Analytical Development Develop and maintain high level of scientific achievements for the company; expected to be a point of contact for project coordination, including email and client meetings Ability to handle regulatory inspections from FDA, EMA, etc.
and cGMP audits from clients, as well as internal audits Ability to work in a team environment and independently as required Perform job specific tasks in compliance with applicable Regulations, International Standards, and WuXi Vaccines Policies and Standard Operating Procedures Other duties as assigned Lead or participate on microbiology projects, including microbial method validation and testing, environmental monitoring, microbial organism identification, supporting facility qualification, cleaning validation, and process validation Perform microbial testing and participate with atypical/OOS investigations, change controls, and CAPAs Work with supervisors and other team members to review and monitor method performance Author of technical documents including methods protocols, qualification / validation protocols and reports, SOPs, etc.
Provide technical guidance, as well as evaluate / introduce new technologies in microbiology area Assist Microbiology Lead to develop micro control strategies, quality enhancement, and operational efficiency improvement Provide effective communication and play a leading role in project management interaction with internal and external clients such as Quality Assurance, Regulatory Affairs, and Analytical Development Develop and maintain high level of scientific achievements for the company; expected to be a point of contact for project coordination, including email and client meetings Ability to handle regulatory inspections from FDA, EMA, etc.
and cGMP audits from clients, as well as internal audits Ability to work in a team environment and independently as required Perform job specific tasks in compliance with applicable Regulations, International Standards, and WuXi Vaccines Policies and Standard Operating Procedures Thorough understanding of current Good Manufacturing Practices (GMP) Education & Experience: Degree in Microbiology or related field.
1-3 years related industry experience Demonstrated experience within highly regulated environment Ability to interpret technical documentation Knowledge of cGxP requirements and regulations Knowledge of trouble shooting and problem-solving skills, e.g., formal root cause analysis such as Ishikawa diagrams, FMEA etc.
Knowledge of microbial testing and microbial control Comfortable in a fast-paced working environment Able to adjust workload based upon changing priorities Demonstrated ability to work well in cross-functional teams