Job Summary
This role involves applying scientific principles to provide data and analytical support for effective data coordination and evaluation services related to process monitoring and modelling of biological drugs.
Main Responsibilities
* Sourcing and verifying process data from various systems, including paper records and database systems (LIMS, Qumas, OPM, Historian), to support timely and efficient data monitoring needs.
* Collaborating with cross-functional departments to ensure process data is used to improve process understanding and facilitate continuous improvement opportunities.
* Developing automated solutions to address specific analytical objectives and facilitate report generation and distribution of analyses.
* Running quality system events related to data integrity and data management, such as investigations, CAPAs, and change controls.
* Applying data visualization tools to translate data into useful information for operations managers and process engineers.
* Analysing data sources and developing strategies and solutions for data acquisition, aggregation, and reporting.
* Providing audit and regulatory submission support where applicable.
Requirements
* Strong communication and interpersonal skills.
* Logical troubleshooting and problem-solving skills.
* A proven track record of communicating effectively with multiple partners.
* Strong mathematics and statistical skills to analyse complex data.
Education and Experience
Bachelor's or Master's degree in Mathematics/Statistics or a related field. Experience in a biopharmaceutical cGMP manufacturing setting is an advantage.