Lab Systems Specialist
A global pharmaceutical organisation are currently looking for an experienced Lab Systems Specialist for a long term contract position based on the east coast of Ireland.
This role is associated with the data management systems for instrument control in the laboratories, this includes but is not limited to Labware LES (LIMS + Execution System), Lonza MoDa and Waters Empower. Below activities are associated with these systems;
- Participates in defining user requirements for Lab IT Systems
- Tests and validates the design of Lab IT Systems
- Develops procedures and training documents for Lab IT Systems
- Assist in the implementation of Lab IT Systems at site
- Build the Lab IT Systems to support Tech Transfer/Commercialisation of the R&D pipeline
- Liaise with end users of Lab IT Systems to ensure IT System build is fit for purpose
- Liaise cross functionally at a site & network level to support commercialization of the R&D pipeline & critical monitoring of manufacturing areas & utilities.
- Configuration, building, maintenance of laboratory management systems such as LIMS/ MoDa and /or Empower systems
- Empower superuser to build and maintain custom calculation builds and system maintenance
- Manage Methods and Calculations on Analytical Instrumentation
- Following all relevant Standard Operating procedures.
- Ensuring strict adherence to site policies, GMP and environmental, health and safety regulations.
- Complies with all pertinent regulatory agency requirements.
- Execution and on time completion of required training activities.
- Participates in Laboratory Investigations as required.
- May interact with outside customers and global support teams or functional peer groups.
- Work within an environment of right first time in everything that we do through a focus on principles of lean, including simplification, standard work, visual management and a learning organisation.
- A Bachelor’s degree Level 8 or equivalent in a technical discipline (e.g. biochemistry, chemistry, engineering etc).
- Previous experience with configuring, building, maintaining laboratory management systems such as LIMS/ MoDa and /or Empower systems and interest in coding/ script.
- Previous GMP laboratory experience in the biotechnology and/or pharmaceutical industry.
- Excellent communication skills (written and oral).
- An understanding of cGMP requirements for manufacturing and/or systems and compliance.
- Required to work on his/her own initiative in addition to working as part of a team.
- Excellent time management & organisational skills.
- An understanding in analytical methodology (e.g. HPLC, ELISA, SDS-Page, Glyco analytic, Bio-Assays, PCR, capillary electrophoresis, compendial assays).
- A working understanding of GMP, ICH, USP and global compendia regulations and guidance's, particularly as related to analytical method development and validation.
- Excellent trouble shooting and problem solving skills.
- Ability to challenge the status quo with a continuous improvement mindset.
The candidate must have the rights to work in the location stated in the job advert.
Please note, Quanta part of QCS Staffing does not sponsor Visa applications.
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