Mundipharma Research Ltd Job Description JOB TITLE: Laboratory Informatics Support Scientist SECTION: DEPARTMENT: Technical Support COMPANY: Mundipharma Research Ltd RESPONSIBLE TO: Section Manager Technical Support DATE: A. Laboratory Informatics August 2012 BROAD PURPOSE OF JOB To provide support for the development, qualification, validation and maintenance of electronic systems including the Laboratory Information Management System (LIMS), Chromatography Data System (CDS), electronic Process Management and Compliance system and Training Database system. To provide support for the processing, collection and storage of data from laboratory instruments using specific equipment applications. B. SPECIFIC DUTIES & RESPONSIBILITIES 1. Undertake a practical and supporting role within the European Technical Development Directorate (ETD), with the aim of making the greatest contribution to supporting electronic systems for the Paperless Laboratory suit of applications and other divisional applications including equipment specific software where appropriate. 2. Carry out routine maintenance for applications, including logging and monitoring of change control requests, creation of user accounts, assignment of application permissions, creation and modification of electronic tests and specifications, development of electronic methods and creation and archiving of projects. Ensure a full audit of all changes is maintained. 3. Review, maintain and update technical documentation such as; Standard Operating Procedures (SOPs), training plans and validation test scripts. Assist with writing documentation as required for technical equipment implementation, upgrades, system fixes and patches. 4. Assist with running test protocols for equipment validation, data migration, patch management and process verifications. Help plan and co-ordinate business continuity for the divisional applications and ensure contingency procedures are viable during the event of application failure. Run reports to ensure system back-up procedures are adequately performed. Where appropriate work closely with the Quality and IT Departments to ensure the appropriate qualification of the work is carried out and the validation status of the equipment is maintained. 5. Provide assistance in the planning and co-ordination of electronic systems requirements for ETD and other departments where appropriate. Provide training to staff to maintain and develop the effectiveness of ETD and help trouble shoot problem areas for the users as necessary. 6. Assist with carrying out training for other team members, in order to maintain and develop the effectiveness of the Department, ensuring individual training records are completed and kept up to date. 7. Take responsibility for personal training and development in order to reach and maintain the required level of skills, knowledge and experience to perform the role. Maintain accurate training records. Proactively participate in the company Performance Assessment System, including the agreement of objectives which meet the business requirements and enable personal development and progression. 8. Ensure all work is undertaken in compliance with the requirements of cGxP (Current Good ‘Clinical, Laboratory, Manufacturing, Pharmaceutical’ Practice), relevant codes of practice (e.g. Medicines Act 1968, EU Directives) and company/departmental SOPs. Ensure compliance with the requirements of Control of Substances Hazardous to Health (COSHH) and Health and Safety at Work Act 1974 (HASAWA). 9. Undertake any other reasonable tasks to help fulfil the objectives of the Department.