Website Celtic Management Services
Job Role : LABORATORY INFORMATION SYSTEMS ANALYST
Location : Ireland , Dublin
The Client discovers, develops, and delivers innovative human therapeutics. A biotechnology pioneer since 1980, The Client was one of the first companies to realize the new science’s promise by bringing safe, effective medicines from lab, to manufacturing plant, to patient. The Client therapeutics have changed the practice of medicine, helping millions of people around the world in the fight against cancer, kidney disease, rheumatoid arthritis, and other serious illnesses. With a deep and broad pipeline of potential new medicines, The Client remains committed to advancing science to dramatically improve people’s lives.
The Client Dun Laoghaire (ADL) is a 37,000 square meter aseptic drug product operations facility, specializing in secondary manufacturing activities – Formulation, Vial/Syringe Filling, Lyophilization and Packaging. The ADL site also includes laboratories and cold chain warehouse capabilities. There is a strong culture of continuous improvement and innovation within ADL to strive for solutions that improve health outcomes and dramatically improve people’s lives. The Client is developing the capability to produce all its medicines in Dun Laoghaire, helping to ensure continuity of supply of our medicines as we expand internationally.
As a member of the Information Systems team, the individual will act main resources to work with QC labs at The Client at full breadth of Information Systems.
At The Client there are various labs with huge range of system and equipment likes SoloVPE, Instrons, Tecans, HPLCs, CEs etc. Which involves day to day sustaining works like User access reviews, periodic reviews, resolving issues and medium to long term projects including system OS upgrades, LIMS, CIMS and LMES upgrades, qualification of lab instruments for our business partners.
Responsibilities (examples of work)
· Under the supervision of the IS QC Lead, Senior Manager of Information Systems, an incumbent in this class manages laboratory information systems at The Client
· Maintenance of Lab systems
· Development of project plans to increase the efficiency of Lab systems.
· Implementation of newer systems to reduce the downtime, incidents and system failure
· Perform systems validation and advise on risk assessments, validation plans, IQ/OQ/PQ, and validation reports for various software’s and systems, working with quality assurance (QA) as needed.
· Conduct change control procedures to maintain compliance. Working with laboratory staff, I.T. and the QA to coordinate and facilitate updates and configuration changes.
· Write and revise standard operating procedures, policies, reports, and other process documentation.
· Participate in team projects that enhance the quality or efficiency of the IT Support Team
· Prepares test plans for system or software upgrades, coordinates, and executes testing, prepares environments, and documents results.
· Acts as liaison with vendors and attends vendor training; Participates in integration of network configurations and system servers to ensure that design meets the system and disaster recovery requirements required by the laboratory.
· An incumbent must possess a high level of technical expertise to enable the technical application of computer analysis for this specialized system.
· Monitors and oversees the performance of the laboratory information system and equipment to ensure that is it functioning correctly and meeting the needs of the department.
· Provide technical support for windows services per requests from various customers and teams.
· Install, maintain, and support a subset of software applications, hardware and peripherals running on the manufacturing and corporate domain.
· Works closely with both the local IS Analyst and the Service Desk, provide back-up and overflow for either role when demand is high.
· Research, resolve and respond to questions received via email, tickets in a timely manner, in accordance with standards.
· Track calls / tickets and enter solution data into corporate ticketing system.
Preferred Qualification/Skills required for the job.
· Possession of a bachelor’s degree and four years of experience where the primary function of the position was analysis, maintenance, and implementation of computer-based laboratory information systems.
· Possession of a bachelor’s degree in computer science, information technology or a closely related field may be substituted for the general bachelor’s degree plasmin 6-7 years of the required experience.
· Good knowledge of applicable GxP principles and project management.
· Ability to analyse functional specifications and information to determine, recommend and plan the layout of computers and peripherals, or to modify existing equipment and systems, so that such systems operate efficiently and effectively; ability to convey both orally and in writing the requirements, design, and operation of all components of the system.
· Ability to instruct in program procedure and system usage; ability to plan and supervise the work of others; ability to establish and maintain effective working relationships; ability to effectively use computer applications such as word processing, spreadsheets, calendar, email, and database software.
· Ability to communicate effectively, both orally and in writing; initiative; resourcefulness; sound judgment; physical condition commensurate with the demands of the position.
Knowledge Good to Have:
• Knowledge of Validation process
• Knowledge of GAMP5
• Experienced in Quality and Manufacturing processes
• Experienced in Benchtop management
• Knowledge of relevant regulations (21 CFR Part 11, GCLP)and software development life cycle.
• Experience working in a GMP pharmaceutical manufacturing environment or other regulated environment.
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