A fantastic opportunity has arisen to join a well-established company that specialise in providing goods for clinical trials globally. Your role will include providing administrative support to the operations and quality team. You will be required to work 2/3 days per week in the office and 2/3 days from home – all equipment will be provided. Flexibility is required for office work, should the days per week need to increase.

Responsibilities

Operations

* Data entry and general administration duties using all Microsoft applications and a variety of in-house systems (training will be provided)

* Liaising daily with the operations and quality teams

* Operational activities on the operations system to ensure that products are correctly received and dispatched

* Recording serial numbers / inbound and outbounds / DSCSA operational process requirements

* Save all relevant files into the Salesforce system

* Conduct monthly reviews of warehouse temperature data and upload the results into the eQMS system (Dot Compliance), ensuring records are up to date

* Handle all inbound and outbound shipments on the system

* Ensuring GDP compliance, documents and invoicing is accurate

* Assist QA with the qualification of the clinical sites (via protocol or hospital site qualification)

Quality

* Regularly review and assess the Suspended and Revoked lists, completing required assessment forms as needed

* Monitor and review lower classification recalls, such as Class 4 (Caution in Use), and respond to notifications from MedWatch (FDA)

* Support the administration and recording of Quality Events, Deviations, and Customer Complaints and where required assist the record owner with the creation / investigation

* Ensure all relevant documentation and corrective actions are available and uploaded in a timely manner, following internal processes.

* Assist with the qualification process of both customers and suppliers by requesting documentation from contacts (as instructed by QA), including support on qualification on regulatory websites (EU/UK/US sites)

* Updating Customer / Suppliers in TrackTrace and establishing the systematic relationships

* Assist with periodic requalification of Customers, Supplier and Delivery Sites

* Liaise with the Commercial Team to inactivate Delivery Sites, Customers and Supplier that are no longer utilised review and closure of order packs within Salesforce as per the QA Order Pack Closure process

* Document Control, ensuring that Standard Operating procedures (SOP's) are up to date and adhered to across the site

* Management and Escalation and recording of non-conformities and quality issues when observed

Skills/Experience

Excellent planning & organisational skills

Multitasking-able to prioritise accordingly, and manage within a fast-moving environment

IT literate

Excellent communication skills, both oral and written

High level of attention to detail

Proactive in problem solving & highly capable decision-making abilities

Ability to work within time constraints

Confidence & conviction