RP/RPi UK and Quality Lead UK/IE
Pleased to meet you, we are Galapagos, a dynamic fast growing Biotech company with offices in Europe in Belgium (Mechelen), France (Romainville + Paris), the Netherlands (Leiden), UK (London), Switzerland (Basel), Italy (Milano), Spain (Madrid), Germany (München), and in US, Boston.
We’re in the business of changing lives. In our quest to discover and develop life-improving medicines we go where no one has ever gone before. In every challenge we face, we see new opportunities. We want to challenge the impossible. We need thought leaders and rapid thinkers, entrepreneurs in spirit and status quo-fighters. Collaborative innovators and perseverant idealists. We need the best-in-class. In other words, we need you: The ‘make-it-happeners’.
We are looking for a Responsible Person Import for our UK affiliate and Quality Lead for our UK & Ireland group.
Scope of the job
as Responsible Person (RP) and Responsible Person Import (RPi) for UK together
with being the Quality Management Local Lead for the UK & Ireland.
Act as Responsible Person (RP) and Responsible Person Import (RPi) for UK
- Ensure that a quality management system is implemented and maintained
- Focus on the management of authorised activities and the accuracy and quality of record
- Ensure that initial and continuous training programmes are implemented and maintained
- Coordinate and perform any recall operations for medicinal product
- Coordinate and perform an annual Mock Recall (if applicable)
- Ensure that relevant customer complaints are dealt with effectively
- Ensure that suppliers and customers are approved/qualified
- Approve/qualify any vendor performing activities which may impact on GDP
- Ensure that self-inspections are performed at appropriate regular intervals following a prearranged programme and necessary corrective measures are put in place
- Keep appropriate records of any delegated duties
- Decide on the final disposition of returned, rejected, recalled or falsified products
- Approve destruction of rejected inventory
- Approve any returns to saleable stock
- Ensure that any additional requirements imposed on certain products by national law are adhered to.
- Act as primary Contact for regulatory authorities and for external consultant in UK, ensuring compliance of Product Information, approval of artworks for packaging materials
- As the Responsible Person import (RPi), maintain a system to confirm that the required QP certification has taken place for products that have been imported into Great Britain from countries on an approved country for import list
- As RPi, ensure that batches of authorised medicines imported from countries on a list have been appropriately certified prior to being placed in the Great Britain market
- Ensuring that written evidence is available to demonstrate that each batch of product has been QP certified as required in Article 51 of Directive 2001/83/EC
As the Quality Management Local Lead for the UK/Ireland:
- Drive all local actions required to enable the local quality management system: Change Control, CAPA Management, Risk Management, Training, Vendor Qualification, Customer qualification
- Coordinate the local audit schedule
- Consolidate UK input for GDP Management Reviews
- Monitor all applicable laws, regulations and national Codes of Conduct to ensure full compliance of GxP-related activities in UK;
- Coordinate all local GxP-related activities in UK and SOP-training related to Quality
- Participate to the Quality related meetings with Affiliates
Who are you?
- Completion of a university or higher education course of study in pharmacy, chemistry, medicine, biology or related life science or an equivalent qualification
- At least two years’ experience in performing the functions of a responsible person on a WDA(H) or equivalent experience within quality assurance function in pharmaceutical manufacturing roles. practical experience in handling, storage and distribution of medicinal products and transactions in or selling or procuring medicinal products.
- Managerial experience in controlling and managing medicinal products on a scale.
- Member of a professional body with a published code of conduct
What’s in it for you?
You will be part of a fast growing and amazing company. As ‘make-it-happener’ you will get all the support you need to make your job successful.
At Galapagos, we recruit the best people, those who stand out amongst their peers, with integrity and excellent interpersonal and organisational skills. Our teams are the strength behind Galapagos, highly motivated, eager to maintain Galapagos’ leading position and achieve breakthroughs in biopharmaceutical research. Galapagos offers a competitive remuneration package and a dynamic work environment.
We are Galapagos: together we can make it happen…!