Purpose
:
Describe the unique value and contribution of the job to the organization briefly
Reporting to the Microbiology Lead, this role will provide online QC oversight to Drug Substance/ Drug Product manufacturing operations. 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.
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 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 Head 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 Vaccines Policies and Standard Operating Procedures.
* Thorough understanding of current Good Manufacturing Practices (GMP)
Requirements
* BSc in Microbiology or related field 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.