5 months ago
A career changing opportunity with a new bio-pharmaceutical start-up. This organisation has recently set up a new European operation in Ireland having recently launched in Europe with an impressive portfolio of products in various stages of development predominantly focused on the treatment of rare diseases . The newly appointed Head of European Quality is looking to a hire a Quality Operations professional to assist in the management of Quality Operations, Commercial activities and GDP practices. If you are looking for a new challenge and to get in at ground level within a start-up environment, then this will be the perfect role for you.
- Support the development and implementation of the long-term Quality strategy and provide overall quality oversight to GDP practices
- Responsible for monitoring and supporting the quality performance of CMO's, distributors and suppliers in terms of GMP and GDP
- Develop and embed a Quality culture into business processes
- Design, implement and improve quality systems
- Lead internal audits where necessary
- Contribute to the development of the annual Quality Plan
- Act as main contact during FDA /HPRA inspections, customer audits and other third party Quality System evaluations
- Develop and implement training for relevant internal staff. Maintain training files and monitor compliance of staff GMP with training
- Bachelor and/or Masters degree in a scientific related discipline
- 7+ years of GMP/GDP experience
- Experience in a virtual organisation or working with CMO’s is desirable
The Next Step for you…
Should this position be of interest to you please forward your CV to Emma Wickham from Next Generation Recruitment or alternatively call on the main line on +353 1 6629120.
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