Job Title: Project Co-ordinator Department: Project Management Reports To: Project Management, Team Manager Summary The Project Co-ordinator organizes or assists with activities involved with the management of clinical/commercial supplies, packaging, and distribution project set up. Essential Duties and Responsibilities Comply with cGMP guidelines. Communicate necessary information to all appropriate departments for the purpose of scheduling and planning. Track and maintain project management reporting logs. Support Project Managers as required. Manage project timelines for execution of deliverables. Ensure components required to support production are available in approved stock and submit requests for procurement where necessary. Prepare Master Batch Records (BR) in compliance with cGMP and SOPs in a timely, accurate and concise manner. Prepare Distribution Instructions (DI) in compliance with cGMP and SOPs in a timely, accurate and concise manner. Responsible for the set-up of activities for Depots and customer portal access. Set up study specific materials (MINS). Generate patient list requests and import patient lists into SAP. Support with the completion of all paperwork required for the projects assigned, in line with cGMP requirements. Support with data entry into specific systems and ensuring data accuracy is always maintained. Document background information for all projects and maintain complete record files. Assist in collaboration with key operating departments to meet internal deadlines for timely completion of requested activities. Work with colleagues to resolve potential conflicts with projects. Inform management and business partners of project delays and recommend appropriate solutions. Adhere to policies, processes, and SOPs to ensure compliance with cGMP, MHRA and any other regulatory regulations and standards. Independently manage deliverables as assigned by Project Managers. Participate actively in regular meetings. Achieve expected performance measures. Other duties as assigned. Basic Qualifications Min of 1year experience within a regulated environment. Excellent attention to detail. Proficiency in Microsoft office packages – high level of knowledge of Excel. Excellent verbal and written communication skills. Team Player Preferred Qualifications Demonstrates ability to work within a regulated environment. Proven track record of performing to a high standard, in line with company SOP’s. SAP experience, in particular in Sales order generation. General: This job description is not exhaustive. It may be amended to meet the changing requirements of the organization at any time after discussion with the post holder. Full training will be provided on company processes, policies and systems. All employees are required to be aware of their responsibilities towards health and safety and the dignity at work of their colleagues in the workplace. Sharp is an equal opportunities employer. We believe that employing a diverse workforce is central to our success. We welcome applications from all members of society irrespective of age, sex, disability, sexual orientation, race religion or belief.