Description
Main purpose of the job:Within the framework of the UK site and the Quality Assurance European Network, and reporting to the Quality Assurance Business Manager, to ensure compliance of the UK business with UK GxP requirements and with Corporate QA policies within his/her areas of responsibility.
Principle responsibilities:
Release of product to the market:
- Raise, review and investigate any temperature deviations relating to delivery of SPMSD products, in order to pre-empt or minimise any potential delays in release (MIF sign off) of product to the UK market. This will require close relationships to be developed with Corporate and the Companies logistics providers.
- To support the QA Assistant in the preparation of al documentation required for batch release (Protocol, GRN, EBR etc)
- To maintain SPMSD's WL licence in the UK, ensuring that it is varied to reflect any changes made at the Companies approved provider for storage and distribution of products to the market.
- To organise relevant documentation/variations that may be needed in order to import unlicensed vaccines to meet healthcare and business needs.
Customer Quality Complaints:
- With the support of the QA Assistant, to be responsible for the processing, follow up and closure of quality complaints, according to corporate policies/timelines and to the Wholesale Dealer's Licence ( WL ) requirements.
- To ensure optimal use of the Company's online feedback system with regard to management of quality complaints by appropriate training of relevant departments
Audits:
- To be responsible for the conducting and follow up of audits to ensure compliance of the UK site with the ABPI code of practice, according to schedules agreed with the corporate audit plan and the UK Medical Director.
- To conduct or give support to other internal and external audits, as requested by the QA Business Manager, in line with the annual audit schedule, and ensure that corrective/preventative actions are put in place according to agreed timelines.
Electronic Document System, Training and Support:
- To have knowledge of the Companies electronic document system such that they are able to ensure any new employees are trained in the use of the system to the level required; to ensure existing employees receive refresher training as necessary and to support any administration functions as required.
- To deputise for the Senior QA Executive as contact with QA Corporate for the electronic document system, ensuring issues are raised in a timely manner and to ensure that the system users are informed of any updates or changes to the system
Please apply if you are interested in this role and I will contact you. Or please call
To find out more about Real please visit www.realstaffing.com