To Deliver stability operations related activities Company & Regulatory standards suitable for the task (e.g GMP, Health & Safety & Company standards) & to conduct other defined packages of work as directed by a Senior member of staff. Main duties: * Executes and manages both formal and experimental stability studies using current defined processes with minimal supervision * Works to and is fully trained in GMP and ensures that the company standards are adhered to at all times with respect to Safety and Quality. * Utilises IT systems and PD packages (e.g. CLS, word, excel) and IMMS for data management. * Participates and takes a lead role in the smooth running of the stability operations functions: including: loading, storing and pulling stability samples using the container management systems in CLS to capture container movements. * May train others in Stability Operations activities (if deemed a trainer). * Manages the Stability Chambers and Cabinets in Building 5 and 11. * Investigates and documents all chamber and cabinet excursion alarms and observations. * May have System Owner responsibilities for Stability Operations equipment. * Generates and reviews the monthly independent check data for Building 5 & 11 stability chambers and cabinets. * Generates and performs reviews of validation documents/Technical reports issued by the stability operations function. * Brings to the attention of their supervisor, any incidents/unplanned events encounters in day to day activities with appropriate observations. * Can perform correct disposal of samples where appropriate. * May assist in generating and collating data for regulatory submissions. * May prepare reports or technical documents related to stability Operations function as required. * May present at Team or Dept meetings. * May contribute to the validation of equipment and/or chambers. Knowledge Technical Skill and Expertise * * * Understands the basic principles, concepts and processes governing their own work and can learn new systems and procedures easily. * Demonstrates competence in using computer systems for data processing and reporting of stability operations data. * Demonstrates competence and experience in proper handling, recording and analysing stability operations data. * Has Knowledge and operates to GxP requirements and all appropriate SOP's and company policies. * Has basic knowledge of regulator rqequirements, if applicable. * Has opertasion knowledge of routing stability operations equipment. Roles & Responsibilities * * * Identifies and beings to interpret any problems in the execution of their day to day role and communicated them to his/her supervisor. * Operate stability operations equipment independently. * Performs data management tasks including recording results effectively with minimal supervision. * Proactively seeks assistance from other staff members to solve problems. * Follows safe working practices and maintains the company standards for own work. * Makes effective decisions to achieve desired outcomes within immediate work group. * Maintains accurate and complete training record consistent with company policies and legal requirements. * Anticipates/recognises potential problems with equipment and/or supplies, and initiates action to solve or prevent problems. * Is fully aware of safety requirements for working in the laboratory and stability operations area's and attends and records regular training to maintain company standards. * Recognises potential safety problems and takes action to rectify them. Communication * Reliable generation and timely reporting of stability operations data in accordance with company policies and legal requirements. * Consults with supervisor when difficulties arise that cannot be readily resolved. * Prepares brief oral or written summaries of data with interpretation for the department. * May write specific technical sections of internal and external reports with or without supervision Leadership Influence and Development of Staff * May guide daily activities of others. * May train others in their area of technical expertise (if they are a trainer) Health and Safety responsibilities: * Follow Group and company policies and procedures at all times; * Report any apparent deficiencies in systems of work or equipment provided that may result in failure of service delivery or risk to health and safety or the environment; * Use all work equipment and personal PPE properly and in accordance with training received; * Report any issues or training needs to your Line manager and /or via your divisional incident reporting system; Information Security: * Ensure compliance with Mitie's information security procedures in all activities; * Proactively identify and report security risks to your manager; * Report actual and suspected security incidents; Note: This job description Is intended to give the post holder an appreciation of the role envisaged for this position and the range of duties undertaken. Specific tasks and objectives will be agreed with the post holder throughout the period of employment. The job description may be varied from time to time by the Company to reflect changes in the post holder's role and/or the needs of the business.