Job description:
Yacht Life Sciences has a vacancy for a GMP specialist – Deviations Lead at Janssen Biologics BV / Vaccines Launch Facility (VLF)

The responsibilities & the impact you will have
As a  GMP specialist – Deviations Lead - you will be responsible for leading the deviation investigations of any deviation that occurs in the manufacturing facility. You will be responsible for the closed loop approach to investigations, including Product Impact Assessments, Root Cause Analysis, and Corrective Actions. You are responsible that progress is documented in a compliant way.  Additionally, you will also work on maintenance and improvement of general GMP processes, as needed. Examples are support in emergency Change Controls, Training, updating general GMP procedures, support in inspections etc.
You collaborate closely with the operations department, the equipment owners and the process engineers and other staff members of the VF. Also, you are a key contact for and work closely with the Quality Department.

As GMP specialist / Deviations Lead you will be responsible for:

• Lead deviation investigation in documenting product impact analysis and root cause investigation, including CAPA records
• Responsible for follow up, and ensuring compliant documentation and timely completion;
• Ensuring that relevant corrections and/or improvements on production processes and systems are made within the VF;
• Monitor progress and KPI for this process
• Act as a Subject Matter Expert on Deviations during inspections and audits

Other areas may include:

• Inspection readiness;
• Support in keeping general VF GMP documentation up-to-date;
• Training coordination and responsible for the training syllabi within the VF;
• Support of documentation periodic review within the VF;
• support internal batch release process.
• Leading process excellence activities to continuously improve the work as well as personal skills.