* Compile, analyse and identify trends in site quality metrics using statistical software as required. Along with another colleague, collate and present the monthly, quarterly and annual reports and collaborate with site personnel regarding ongoing actions. Collaborate with teams at other sites to manage required reporting of quality metrics from the Cork site.
* Provide support for onsite departments in assessing and approving quality system records such as deviations, change controls and document updates.
* Represent QA on global Quality System related initiatives such as Global Risk Management and other improvement projects impacting application of Quality System.
* Support the management and updates to the Quality Risk Register.
* Participate in and lead improvement initiatives for the Quality System on site.
* Participate in developing Standard Operating Procedures (SOPs) to ensure quality objectives are met.
* Participate in the development and delivery of Quality System related training programs.
* As required lead investigations and corrective and preventive actions (CAPA) for QA relevant investigations.
* Participate in and lead internal audits and walkthroughs on site and provide assistance in compliance audits as required.
* Maintain routine programs and processes to ensure high quality products and compliance with current Good Manufacturing Practices (GMPs).
Normally receives no instruction on routine work (after relevant training is completed) and general instructions on new assignments.
* 6+ years of relevant experience in a GMP environment related field and a BS or BA.
* 4+ years of relevant experience and a MS.
* Demonstrates proficiency in application of QA principles, concepts, industry practices, and standards.
* Demonstrates thorough knowledge of FDA / EMEA standards and quality systems, and the interface with other functions like manufacturing, distribution and maintenance.
* Demonstrates strong verbal, technical writing, presentation and interpersonal skills.
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