The successful candidate will be required to implement and execute QP related tasks, duties and certification actions associated with manufacturing processes.
Responsibilities
Maintain compliance with GMP.
Manage customer expectations as defined in Quality Agreements/Frameworks.
To review batch manufacturing documents to ensure compliance with EU GMP.
To certify Medicinal Products for use inside and outside of the EU.
Regularly participate in meetings with customers, to ensure current business needs are fulfilled and support continuous improvement projects including new product introductions.
Keep up to date with the requirements of national regulatory authorities across Europe.
Provide guidance and advice to our staff and Customers regarding QP requirements within the EU.
Provide assistance and input with relevant elements of the Quality Management System (QMS).
Undertake audits in EU and other countries to ensure that manufacturing sites are operating in general compliance with EU GMP.
Experience
QP certification activities with investigational and commercial medicinal products.
Experienced in sterile and non-sterile dosage forms.
EU GMP audits of third country manufacturing and testing facilities.
Demonstrable experience of packaging and processing, within the pharmaceutical or medical device industry.
Knowledge
Expert knowledge of GxPs within pharmaceutical industry for medicinal products.
High level knowledge of Quality Management Systems and principles.
Eligible to act as a QP for certification of marketed and investigational medicinal products, in accordance with EU and local legal requirements.
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