- An opportunity to join one of the fastest growing generic pharmaceutical company
- With prospects for continue growth and development
About Our Client
The client are a leading pharmaceutical company with ambitious growth plans for the future. They have sites across the globe within wider group, and are rapidly growing their Newcastle facility.
As a QP you will be responsible for:
- Ensuring current and future EU/UK GMDP requirements are met and that an effective Pharmaceutical Quality system is maintained
- Supporting the Site Quality Head in maintaining and continuously improving GMDP standards
- Building in-house know how, capacity and capability within the quality team to support business growth
- Supporting a common Quality Culture and Accord everyday business behaviours to support collaborative working relationships between operations and quality functions
- Lead site inspections and communications with Regulatory Authorities related to GMDP
- Support the Quality Management Review process and reporting the site quality performance to senior management
- To perform the Qualified Person duties in accordance with Directive" 2001/83/EC (amended by Directive 2004/27/EC) and following the guidance laid down in Annex 16 of Eudralex Volume 4 - Good Manufacturing Practice.
- To carry out the routine duties of a Responsible Person in accordance with the EU GDP Guidelines 2013/C 343/01 and to ensure that all conditions of the Wholesaler Distribution Authorisation (WDA) are met
The Successful Applicant
As the successful candidate you will have:
- Experience in working as a qualified person within manufacturing facilities including batch certification
- A detailed understanding of oral solid dose manufacture / packing and related product transfers
- Experience of importing and certifying products from outside the EU
- Experience of hosting MHRA GMDP Inspections
- The ability to be a decisive thinker and able to progress actions to a schedule
- A practical approach to developing and implementing procedures and processes within a regulated environment
- An excellent communicator, who can interact effectively on a global level and at all levels within the company
The ideal candidate will have experience in sterile manufacturing, however other applicants will still be considered.
What's on Offer
The company are offering a fantastic package in an exciting and dynamic environment, with opportunities to develop moving forward as they continue on their ambitious growth plan.