Qualified Person Permanent

Qualified Person – Berlin

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.
• Educated to Degree Level (Pharmacist).