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 investigations and change plans.
- Work on continuous improvement projects
About You:
- BS (or equivalent experience), with at least 2 to 5 years of relevant experience
- Strong working knowledge of GMP systems such as Trackwise, SAP, LIMS, MES systems are preferred
- Experience with cGMP documentation and record maintenance
- Experience with Regulatory inspections is required
- Strong ability to lead and drive cross functional teams
- Excellent attitude towards work, with strong drive to drive tasks to closure
- Agility, able to work under stress and cater to different priorities
- Good presentation and strong technical writing skills
- Good interpersonal and communication skills
Duration: 12 months. Option to extend depending on business needs.
