QC Expert

  • Cork
  • Permanent
  • JO-1708-62754_1502296356


Job Description
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


  • BA or BS in a technical discipline (physical or biological sciences preferred but not required) with 4+ years related to pharmaceutical manufacturing.
  • 5+ years' experience in a GMP regulated environment, with exhibited knowledge or proficiency in a qc, compliance or quality role.
  • Experience leading and implementing projects
  • Demonstrated ability to influence peers and teams with no direct reporting lines.
  • Ability to speak, present data, and defend approaches in front of a variety of audiences.
  • Organizational skills to contribute to department and cross-functional projects
  • Familiarity with FDA & European GMP's and regulatory requirements, guidelines, and recommendations.
  • Strong proficiency with Trackwise
  • Technical writing must be at a high level with proficient spelling, grammar, and typing skills preferred.
  • Proficiency with standard office software applications, including MS Word, MS Excel, MS Project, MS Power Point. Experience and proficiency with other applications.

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