The purpose of the role is to provide analytical and compliance related support for the External Supply Operations (Chemicals) quality control related activities performed for the materials under the scope of ESO (Chemicals) responsibility.
* Approve and close out of OOS/OOE and laboratory deviation investigations and actions
* Monitor, progress and follow up corrective actions and preventative actions
* Assess events and their root causes, ensuring appropriate corrective and preventative actions
* Period review of quality related KPIs
* Provide guidance to QC on cGMP relevant queries
* Participate in root cause investigations
* Prepare and deliver general quality related training programs
* Update/approve documents to ensure compliance with cGMP
* Perform internal audits and gap analyses
* Participate in internal/external audits
* Review all documentation including C of As, OOS deviations prior to batch release
* Making final decision on appropriate status for APIs and disposition appropriately
* Manage the timely disposition of all APIs whilst ensuring OTIF is met.
* Raise complaints for confirmed OOS
* Co-ordinate or participate in local or global projects
* Support implementation of quality manual and perform gap assessments as required
Fastnet has a strict confidentiality policy - please be assured that your details will never be forwarded to any third party without your consent.
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The Life Science Specialists