* 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.
* 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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