The Information Systems Analyst is responsible for the maintenance, qualification and validation state of laboratory instruments, systems and computerized systems. The Information Systems Analyst does not generate any GMP data.
Advises the relevant departmental Heads on the content of the preventive maintenance program and/or Laboratory Validation Master Plan (LVMP).
Coordinating maintenance and re-qualification operations in accordance with the preventive maintenance program (laboratory validation master plan) and associated protocols, as well as maintaining/improving equipment documentation.
On an annual basis supports the creation of an investment & replacement plan for laboratory instruments & systems based on the agreed depreciation period of laboratory systems, maintenance logs and new developments within the field.
Provides support for the testing of new and existing software applications under development or consideration for purchase (e.g. Design Qualifications, Software Installations).
Performs and/or coordinates (the outsourcing of) troubleshooting for incoming problem tickets from end-users to resolve application and software issues for laboratory instruments.
Liaising with the relevant departments to support the execution of calibrations and/or qualifications.
Performs hands-on fixes at the desktop level, including installing and upgrading software, installing hardware, implementing file back-ups, and configuring systems and applications.
Communicates application problems and issues to key stakeholders, including management, development teams and end users.
Authoring Validation and/or Qualification Protocols to ensure compliance with Corporate CSV methodologies and procedures.
Writes/reviews procedures and work instructions related to the use and/or administration of laboratory instruments and/or systems.
Trains/advises colleagues within Alcami on the use of laboratory instruments, systems and computerized systems.
Supports customer and/or regulatory audits on the topic of laboratory instrument qualification, maintenance and calibration.
Ensures timely completion and compliance with cGMP and all other relevant company training requirements.
Successful realization of maintenance and successful coordination of qualification and calibration activities in accordance with the predetermined Laboratory Validation Master Plan with respect to timing, quality and costs.
Timely escalation of defects, failures, damage to appropriate site management.
Good documentation of the calibration, validation and maintenance carried out or coordinated by the Information Systems Analyst.
Compliance with the relevant procedures in terms of quality (including ICH Q7A GMP for APIs), safety, health and environment (including ISO 14001).
Symeres is one of the leading chemistry CROs in Europe. With over 450 highly trained and dedicated chemists, Symeres provides a range of services to support small-molecule drug discovery and development projects for biopharmaceutical companies in the USA, Europe, and Japan. Our key areas of expertise are synthetic chemistry, medicinal chemistry, parallel chemistry, and chemical process R&D for clinical trials.
You will be employed by YER and seconded to Symeres. We offer:
Good employee benefits
Excellent guidance from your consultant and YER's back office
Friendly atmosphere and open culture
Community/network with other technology professionals from a variety of multinationals
Events and master classes with interesting speakers and attractive companies
Bachelor’s degree in Chemistry, Computer Science or related field
A minimum of 3 years’ working experience in a chemical industrial work environment.
Strong analytical and technical skills.
Strong level of initiative and flexibility.
Proficiency with Microsoft Office (Word, Excel, PowerPoint) required.
Working knowledge of cGMP in a pharmaceutical or regulated environment preferred.
Working knowledge of laboratory systems/instruments, software applications (Empower, OpenLAB) preferred.