Domain Expert(Microbiologist) with Airamatrix(AI Product Company)

Domain Expert Pharmaceutical Microbiology

Professional who can analyse the business needs with respect to automation in pharmaceutical

microbiology workflow, then designs, implements, and configures software solutions to optimize

their business processes by translating business requirements into functional specifications.

Key responsibilities:

• Requirements gathering:

Conduct in-depth analysis of client business processes to understand their needs, automation

possibilities and areas for improvements

• Solution design:

Translate business requirements into functional specifications, designing system configurations to meet those needs. 

• System implementation:

Configure and customize the chosen software application based on the defined specifications. 

• User training:

Develop and deliver training materials and sessions to end-users on how to effectively utilize the

new system. 

• Client relationship management:

Build strong relationships with clients, manage expectations, and provide ongoing support. 

Skills and Qualifications:

• Microbiology:

Ability to analyse the growth and behaviour patterns of all forms of microorganisms.

Microbiologist should be able to classify microorganisms found in collected specimens. They should be able to quantify bacterial and fungal colonies

• Workflow Management Software

Strong understanding of Software for managing the workflow for environment monitoring and

quality control in pharmaceutical manufacturing.

• Risk Assessment

Knowledge of aseptic process risk assessment and evaluation of sampling locations for environment

.Monitoring.

Understanding of the risk assessment process for airflow and air classification based on

aseptic processes like filling, filtration, lyophilization and capping

• Qualification and Validation

Understanding of the qualification protocol and smoke study protocol.

• Media Fill

Understanding of media fill process and ability to monitor aseptic practices during routine

production and media fill runs

• Monitoring

Understanding of the aseptic operations, environmental monitoring activity for viable particle count (VPC) and non-viable particle count (NVPC). Understanding of various sampling methods and practices (personal monitoring, settle plate, surface sampling, airflow monitoring) testing methods, utility monitoring and non-EM sampling methods.

• Regulatory Principles of Guidelines:

Exposure to principles and practices associated with PDA, USFDA, Warning letters related to aseptic practices and sterility assurance, EU Guidelines, GAMP etc.

•  Process quality and documentation

Knowledge about the SOPs on EM monitoring activities and quality control in used in pharmaceutical manufacturing set ups. Ability to prepare SOPs and study protocols.