QC Chemist III

  • Cork
  • Permanent
  • JO-1907-64678_1565173795

Summary

RESPONSIBILITIES:

* Leading root cause investigations to support QC OOS/OOT and deviations, ensuring all activi-ties are performed in a timely manner and in compliance with procedures and regulatory requirements.

* Ensuring corrective & preventative actions are appropriate, implemented as planned, and has the intended effectiveness.

* Identifying recurring events and ensuring appropriate actions are taken.

* Developing a metrics and reporting system for QC compliance issues and an escalation pro-cess for same.

* Leading and managing change controls to support QC commercial operations, where re-quired.

* Support an internal compliance programme within the QC department. Participate in Global initiatives where required.

* Lead the self-inspection programme and inspection readiness efforts for QC department.

* Interact with the QC staff regularly to answer questions related to GMPs and help champion a compliant work environment with a continuous improvement focus.

* Work with the QC team to develop robust training programs.

* Prepare and deliver general quality related training programs.

* Participate in internal/external audits, as required.

* Lead or participate in QC and/or cross functional projects.

* Update/approve documents to ensure compliance with cGMP.

REQUIREMENTS:

* Requires at a minimum BS degree in a scientific discipline.

* 5+ years experience in a GMP regulated environment, with exhibited knowledge or proficiency in a compliance or quality role.

* Expertise in Trackwise an advantage.

* Experience leading and implementing projects.

* Analytical techniques such as dissolution, Karl-Fischer, UV spectroscopy, Chromatoraphy.

* Ability to speak, present data, and defend approaches in front of a variety of audiences.

* Organizational skills to contribute to department, cross-functional or global projects

* Familiarity with FDA & European GMP's and regulatory requirements, Annex 11, guidelines, and recommendations. Good documentation Practices and Data Integrity.

* Prior experience in pharmaceutical industry

* Experience in electronic data integrity, audit trail review, administrator activities.

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