Job Scope: To perform investigations, change plans or other functional support associated with cGMP manufacturing operations within the biologics production facility and work cross functionality. Responsibilities: Perform technical writing and investigation of non-conformances in collaboration with Operations
Identify and put in place appropriate corrective and preventative actions in conjunction with Operations team Change Management
Structure common Operations Training modules and Train new hires on such modules
Trends Key Performance Indicators and implement measures to streamline work processes and procedures GMP Document Authoring and Revision
Electronic Batch Record Co-Authoring, Revision and improvement
Participates / leads operations improvements and new product introduction projects
Work with Quality systems (e.g. CAPA and change plans) and Operations
Related System (LIMS, SAP, PI, Maximo, MS Office)
Assist in regulatory inspections, detailing investiga...