Durbin is one of the world’s leading specialist medical suppliers and an integral part of Uniphar’s Product Access division. Established over 50 years ago, Durbin offers a bespoke distribution platform to provide patients with access to unlicensed and speciality medicines in over 160 countries. With offices and warehousing in the UK, Europe and USA, Durbin prides itself on being a trusted global partner to healthcare manufacturers.
Durbin has grown rapidly over the last five decades and our multi-lingual workforce includes pharmacists, medical engineers, and nurses, as well as commercial, warehouse and logistics staff.
This is a fixed term contract for 6 months
Objective:
The Quality Officer is an integral member of the Quality Team, dealing with GDP aspects for Suppliers and Customers, Import and Export, Medicines, Medical Devices and other Healthcare Industry products. Work varies greatly from day to day and, once full training is given, the incumbent will be expected to organize their workload continuously, with guidance from the Team Leader.
Essential:
- Proven experience of working within quality assurance in pharma industry
- Experience in QMS, handling change controls, CAPA, deviations, risk assessments
- Experience handling complaints, recalls, MHRA alerts and notifications
- Essential PC skills, including Microsoft Office, Excel and Outlook.
- Ability to quickly adapt to the new processes and various IT systems.
- Excellent organisational skills.
- Excellent attention to detail.
- Good understanding of confidentiality.
- Adapt to working under pressure in a fast pace environment.
- Ability to work independently.
Desirable:
- Knowledge and understanding of storage and distribution of pharmaceuticals under GDP
- Knowledge and Experience of working with Controlled Drugs
- Experience of using Q-pulse
Main duties and Responsibilities:
- Completing drug and license applications for import and export of drugs (Home Office)
- CD license endorsements
- Customer/supplier approval
- Customer complaints investigation and closure
- Handling customer product returns
- Investigate temperature excursions
- To handle and action product recalls
- To authorise customer returns/credits and product destruction
- To review and sign off COCs for the sales departments
- To provide assistance / guidance to company personnel
- Trending and monitoring activities within the department
- To handle PV complaints
- QMS, change control, CAPA, deviations
- Risk assessments
- Other duties as instructed by the Quality Team Leader/Head of Quality & Compliance
- To carry out the relevant GDP SOP’s as instructed by the RP of the Company.
- Other duties which may be reasonably required from time to time by company managers, including delegated duties during the absence of colleague.
Job Type: Full-time
