Operations Manager - Clinical Packaging / Supplies

Atom Recruitment Ltd
From £50,000 to £60,000 per annum plus benefits
29 Sep 2016
22 Oct 2016
Contract Type
Our Client is an independently owned and operated company that works exclusively with clinical trial materials. They provide primary packaging of solid oral dosage forms (tablets or capsules) into bottles or blister strips, secondary packaging (labeling and kitting) of any dosage form into plain packaging to ensure blinding of supplies for clinical trials, and storage and distribution of materials for use in clinical trials. Their facility near Reading serves as the distribution hub for the packaged clinical trial materials to Europe and the rest of world. They are now seeking an Operations Manager to join their dynamic team. This position is a full-time permanent role reporting to the Managing Director and will be based near Reading, Berkshire. Job Purpose This position is responsible for assisting in the management of the Operation and Distribution groups and assuring overall GXP compliance with all procedures affiliated with receiving, storing, distributing, returns processing and disposition of clinical supplies. Supervises Warehouse Group (including Receiving, Distribution, Returns/Disposition) and Secondary Packaging Group Key Areas of Responsibility Oversees all GXP activities related to receiving, storing, secondary packaging, distributing, returns processing and disposition of clinical supplies. Assists and ensures that all Operations personnel follow and perform all policies and SOPs in accordance with EU GMP/GDP. Assures that qualified individuals are EU GMP/GDP trained to perform their respective job relative to handling and/or processing clinical supplies. Monitors and ensures EU GMP/GDP compliance of all clinical supplies from Receipt though Distribution. Coordinates with other departments to meet project timelines. Coordinates with Quality Assurance to maintain EU GMP/GDP and SOP compliance within the Operations and Distribution groups. Participates in planning meetings. Participates in project tracking meetings. Assists with the creation and revision of SOPs. Participates in client audits and visits as appropriate. Oversees the generation of, and review of, shipping documentation processing, and the processing of all shipments of clinical supplies. Oversees and approves the creation and revision of shipment documentation formats for client specific proposals. Investigates and resolves discrepancies in coordination with Quality Assurance department. Maintains close contact with clinical sites and client contacts, couriers, custom brokers, and domestic and/or foreign shipping regulation organizations. Resources, provides analysis and oversees sub-contracting of courier services. Oversees Warehouse group to ensure the management of all drug product and ancillary materials and the material flow of these goods as well as the operational activities that support the maintenance of the facility and use of the equipment. Participates in MHRA and client audits as needed. Assures adherence to standards of personal and packaging safety. Participates in supplier negotiations to ensure product relevance and cost-efficiency. Qualifications and Experience BSc or equivalent MBA or Masters degree desirable Solid experience in warehouse operations and secondary packaging, especially for clinical trials is essential Familiarity with the pharmaceutical industry Managerial experience Familiarity with GXPs (GDP / GMP) Excellent interpersonal skills Excellent reading and writing skills Excellent communication skills English literacy General mathematical skills Computer literacy skills Attention to detail In return our client is offering a competitive package for the successful Candidate including a basic salary of £50,000 - £60,000 (negotiable dependent on experience) per annum plus benefits Please send your C.V and covering letter to Lorraine Roger, Director at Atom Recruitment Ltd. This job was originally posted as www.totaljobs.com/job/66751025