Expert in pharma Suite and AMPS specific functionalities
Good understanding of biopharmaceutical manufacturing including formulation, aseptic, drug substance processing and packaging processes.
Exp with agile software development and JIRA
Exp in ALM.
Exposure of automation tools like Qtest and Tosca
Possesses expertise in good documentation and good testing practices
Experience Required
8+ years
Roles & Responsibilities
Execution and coordination of responsibilities that include Master recipe creation, master data creation, maintenance and control of MES activities .
Process mapping (vizio), recipe designing , testing , dry runs and business verification of the created recipes.
Participate in workshops with stakeholders (business, quality , compliance, product SME) and get aligned with the process flow with respect to the recipe designs.
Building , testing and verifying of recipes which require integration (SAP,IMS, catalyst)etc.
Coordination with core and site teams for new site specific requirements.
Ability to work with site SMEs to turn paper batch records into EBRs utilizing existing functionality.
Ability to work with site SMEs to turn existing EBRs in legacy systems(P2C2, PMX, etc.) into latest EBRs utilizing existing functionality.
Ability to design building blocks that can be reused in multiple processes.
Ability to work in a fact paced agile team environment.
