Laboratory Technician: LIMS, SIMS, Methods Transfer Validation

Laboratory Technician: LIMS, SIMS, Methods Transfer Validation

A world renowned pharmaceutical organisation is seeking a laboratory technician to support the technical lead on definition of commitments and plan analytical activities for the different sites to ensure these commitments will be met (development, evaluation, validation, documents issuance, waiver redaction). The successful candidate will participate in a variety of projects by conducting routine testing and transferring analytical methods and design complex study designs and write protocols, reports and procedures autonomously as study director.

Further responsibilities are as follows;

*Participate to transfer of analytical method according to study protocol. Ensure all reagents, raw materials and equipment are available to run testing design, perform experiments, document activities in an appropriate way and advise supervisor in case of deviation or failed acceptance criteria
*Transfer results and review it in a critical way, ensure deviations are documented correctly
*Advise supervision when facing issue and propose options to meet timelines or provide new timelines in case of troubleshooting
*Conduct the investigation on failed acceptance criteria with minimal assistance. Analyze data, propose hypothesis and document investigation accordingly
*Review reports to ensure data accuracy and completeness
*Perform laboratory testing in a qualified environment following procedures (equipment and analytical procedures) and local or global processes, with respect to timeline and planning assigned to the team
*Work with software in place (SIMS, LIMS, Equipment's' software, development and statistical tools (e-noval, MVM, fusion, minitab)
*Ensure appropriate archiving of all documents associated to laboratory activities.
*Identify requirement in terms of equipment and reference standards for sites impacted by the project
*Participate actively to technical team meeting to give a status on analytical activities and ensure interactions with the different functions of the team (PMO, Mgt, RA, Sol DEV, Container, ).
*Anticipate and communicate in an appropriate way possible delay on timing due to limited resources or equipment availability, propose alternatives and challenge the appropriateness of activities.