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Quality System Manager

3 months ago


Newcastle upon Tyne, United Kingdom Planet Pharma Full time

We are looking for a Quality System Manager to join a rapidly growing global pharmceutical company to intergrate and manage a brand new Quality System. You will be responsible for supporting the transistion from a paper based system to a newly selected tech based QMS.


This is an exciting opportuity for the right person to put there own stamp on Quality Systems and processes and well as a step into people management.


Responsibilities:


  • The objective of this role is to continue the globalisation of the QA processes with the creation of a QA manager position, involved in the development of the quality processes, and operationally responsible for their ongoing maintenance within the organisations.
  • The QA Manager will be responsible for the Quality System processes according to the highest standards of accuracy and will ensure that all administration relating to these tasks is always maintained and up to date.
  • The objective is to ensure the compliance of the pharmaceutical processes with the GxP and applicable National and International regulatory guidelines, and to maintain the Quality system in an auditable state at any time.
  • With the assistance of the QA officers, and in close collaboration with the other QA team member, the QA (System) manager will manage the processes related to the QA documentation (creation, distribution, training and withdrawal), deviations, complaints, CAPAs, change controls.
  • Excellent knowledge of quality regulations in the US and EEA is required.


Required Skills:

  • Previous significant experience in equivalent roles, such as a pharmaceutical quality assurance role within a wholesaler or manufacturing setting.
  • In depth knowledge and understanding of GxP such as GDP, GMP, GVP.
  • Previous significant experience in an international context.
  • Proven experience of having implemented or maintained quality systems using an electronic quality management system (eQMS) such as Veeva QualitySuite, Qualio, Trackwise..

To Apply

If you would like to discuss this vacancy further or to discuss your career options in confidence, please either contact Treasa Alterskye on talterskye@planet-pharma.co.uk


If this role isn’t suitable for you, please let us know if you can refer anyone – any recommendations are much appreciated Planet Pharma offers a competitive referral scheme, so you will be rewarded for your help


We are an equal opportunities Recruitment Business and Agency. We welcome applications from all suitably qualified candidates regardless of their race, sex, disability, religion/belief, sexual orientation or age. Planet Pharma is an Employment Business providing Global Staffing services.