Logistic Specialist QA - Marlow, United Kingdom - Kyowa Kirin International plc
Description
Overview:
- At Kyowa Kirin International (KKI), our purpose is to make people smile. This means more than drug discovery and development; it is about embedding care into everything we do to make a difference every day for those that need it most. We're an inclusive pharmaceutical company that takes time to understand what really matters to our patients, their families, and their healthcare professionals, helping our people to take bold actions that deliver lifechanging solutions sooner.
Our culture is rooted in our values:
Teamwork, Commitment to Life, Innovation, and Integrity. They help us to push boundaries to deliver extraordinary impact and make KKI a brilliant place to work.
Job Purpose:
Responsibilities:
- Support appropriate level of QMS GxP documentation reviews are carried out within KK, as necessary, to ensure ongoing QMS compliance. This includes supporting complaints management as required.
- Monitor and provide regular reports of key performance indicators to KK management, as part of the Quality System, so that the appropriate resources can be allocated and actions are implemented, as necessary.
- Key user on the electronic Document Management System, including system administrator and training requirements.
Qualifications:
- Life Science Degree qualified with minimum 5 years' experience
- Specialist knowledge or experience of pharmaceutical QMS processes and practices.
- A broad experience of working within the pharmaceutical industry operating in a manufacturing/distribution site.
- Excellent working knowledge of international QMS GxPs, especially in the interpretation of MHRA and FDA requirements, for the manufacture, control and distribution of commercial product and clinical trial materials
- Working knowledge of the regulatory requirements for validation activities as applied to computerised systems.
- Working knowledge of GxP requirements.
- Computer skills required (Word, Excel, PowerPoint etc.)
