Specialist, Deviations (Fixed Term Contract)

Job Summary

The Deviations Specialist will play an important role in the department by unblocking, investigating and authoring deviation reports. Deviation Specialists also participate in Out of Specification analysis investigations, closing batch documentation prior to release and communicating with internal stakeholders / SME and Client. In addition, the Specialist will act as a point of contact between the Manufacturing group, QA, Client and regulatory agencies.

18 Month Fixed Term Contract Position.

Major Responsibilities

• Responsible for identifying recurring Deviations/Non-conformances and ensuring appropriate actions are taken.
• Capture immediate actions and initial impact in deviation records to help ensure issues are remediated prior to proceeding with manufacturing.
• Effectively and efficiently write deviation investigations.
• Develop an investigation strategy, perform Root Cause Analysis by selecting appropria...