Quality Assurance Associate
About the role
Norgine, a European pharmaceutical company, is looking to recruit a Quality Assurance Associate
to help manage controlled documents in Norgine’s electronic document management system, to
support the Quality Event and CAPA management systems and to support the implementation of
an electronic Quality Management System- all at the Global Quality level. The successful
candidate will have an innate ability to manage documents and records from multiple sites and
functions. As such you will have a highly analytical mind-set and have previous experience and
understanding of quality systems within the Pharmaceutical or Medical Device Industry. You will
be a personable individual with high professional credibility whom approaches tasks with
meticulous attention to detail so that elements of Norgine’s Quality Management System remain
compliant to regulatory requirements. You’ll ideally be a natural influencer, have solid
communication skills and be someone who is comfortable liaising across the business. As our
Quality Assurance Associate you will also act as project support for the implementation of a new
electronic quality management system throughout the business and as such must be a pragmatic,
flexible and a supportive team member.
About the company
Founded in 1906, Norgine is an independent European specialty pharmaceutical company. We are
focused on the development, manufacturing and marketing of medicines for important areas of
healthcare, where we believe our skills, experience and resources can improve patients’ lives – we
focus on three core areas gastroenterology, hepatology, critical and supportive care. Collaboration is
a way of life for us. As One Norgine, we are dedicated to working with each other and with our
stakeholders. Inventiveness, flexibility and teamwork are at the heart of what we do. It’s what makes
us different.
There are a number of key attributes you’ll need to have for this role:
 You’ll hold a BSc Degree, or diploma in Science, or related discipline.
 You will ideally have knowledge of GxP and/or Medical Device requirements
 Experience/Knowledge of Quality Management Systems (Document control, change control,
deviation, CAPA systems, audits)
 You’ll have strong Microsoft office skills, and SharePoint experience is desirable.
 You’ll be confident, pragmatic and have a strong work ethic
 You’ll have exceptional communication skills (verbal, written and presentation)
Main Duties and Responsibilities:
 Act as a deputy to manage all controlled documents within eGSOP (Qumas ComplianceSP)
o Uploading draft documents to the system.
o Entering meta-data for new/revised documents.
o Workflow management (e.g. terminating workflows, re-assigning workflows).
o Initiating Change Requests in the system for new/revised/withdrawn documents.
o First line support for users.
o Training of new starters at the site on use of the eGSOP system.
 Act as a deputy to manage the global Quality Event and CAPA system
o Log Quality Events and CAPAs onto a central tracker
o Review, assess, or if required allocate the Quality Event and the CAPA
o Management of status updates for Quality Events and CAPAs
o Monthly status reports to Functional Management
o Lead/Support transfer of QE and CAPA system from a paper based to a SharePoint
system.
 Provide project support for the implementation of the global Electronic Quality Management
System
Human Resources
Last Updated 05/01/2015
Knowledge and skills:
 BSc degree, or diploma in relevant field
 Well-developed planning skills and ability to meet deadlines.
 GxP and pharmaceutical industry experience.
 Thorough understanding of Quality systems
 Experience in electronic Quality Management Systems desirable
Human Resources
Last Updated 05/01/2015