* Provides to the site knowledge and experience in Quality Systems.
* Uses knowledge to improve Quality Systems, solve problems, provide continuous improvement and execute tasks.
* Provides compliance contribution to project teams and leads small projects.
* Coaches and guides colleagues within the site.
* Understands and applies regulatory / compliance requirements to their role together with remaining current on upcoming regulatory and compliance changes.
* Responds to non-standard requests from customer needs.
* Makes decisions within guidelines and policies which impact own priorities and allocation of time to meet deadlines.
* Supports Corporate Quality to ensure actions related to Quality Systems at the site are executed.
* Participation in inspections of Site by Divisional / Regulatory Bodies / third parties together with follow up actions where applicable.
* Participation in and leading internal inspections
* Supplier management oversight
* Ensures supply of high quality product through the implementation and oversight of the Quality Management System for the site.
* Champion the highest Quality and Compliance standards for the site.
* Ensure highest safety standards.
* Degree or 3rd level qualification (Science, Quality).
* Demonstrated knowledge in more than one pharmaceutical and/or chemical manufacturing operation
* Experience in the Pharmaceutical industry or a similar operating environment which includes experience in a Quality function
* Quality Assurance SME knowledge, from both operational and educational experience, is required
* Knowledge and experience in interpreting current regulatory requirements and providing independent support to the site
* Demonstrated ability to work independently and fully realize improvement initiatives with a moderate level of guidance
Fastnet has a strict confidentiality policy - please be assured that your details will never be forwarded to any third party without your consent.
Fastnet - The Talent Group
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The Life Science Specialists