Over de functie
The Quality Engineer will be responsible for the initiation and completion of process deviations investigations aimed at identification of root cause, and implementation of corrective actions to prevent recurrence.
• Strong project management, time management, analytic and related leadership skills.
• Work on the manufacturing floor and across the site for data gathering from various sources.
• Performance of Root Cause Analysis (RCA) to determine the most likely cause of the deviation.
• Identification of Corrective and Preventative Actions to reduce deviation recurrence.
• Align internal review team and area subject matter experts on an agreed investigational path forward,
author investigations and support resolution through experimental DOE and execution.
• Ensures robustness (complete, accurate and defendable) of all critical and major investigations.
• Ensures all CAPAs are implemented through cGMP systems (e.g. MBR revision, training, etc.).
• Monitor and ensure effectiveness checks of CAPAs are conducted Communication and Process
• Provide timely updates to management on status of all GMP-related investigations.
• Identifies opportunities for operational improvements for both manufacturing, deviation and
investigation management non-conformance events.
• Clock in and out for every scheduled shift in a timely manner.
Maak het verschil
Set Yourself Apart: Profile/Experiences
• Bachelor of Arts/Science preferably in Biochemistry, Chemical Engineering, Biology or other relevant
• 2-4 years’ deviation investigation experience in a manufacturing environment preferred.
• Strong technical writing capability including efficiency using Microsoft Office Suite.
• Familiarity with cGMP working environment and quality systems.
• Ability to manage multiple ongoing projects concurrently.
• Strong meeting facilitation and conflict resolution skills.
• Participation in the Daily Management meetings to update leadership on deviation statuses.
• Analytical and problem-solving skills.
• Flexible and able to adapt to company growth and evolving responsibilities.