Job DescriptionTesting of pharmaceutical substances raw materials and drug substances in a GMP environment in accordance with clients' procedures and quality systems.
Main focus will be chromatography analysis, along with a range of other analytical techniques as required.Key AccountabilitiesReceive training from SGS and client and get qualified in relevant analytical techniques.
Maintain own training 100% current.
Train other analysts where appropriately qualifiedCarry out testing in accordance to the valid testing procedures and regulatory requirementsEnsure that laboratory equipment is well maintained, and calibrations are carried out at the designated frequenciesManage inventory and status of materials required for analysisWhen qualified to do so, verify and review results generated by other analysts for compliance with requirementsEnsure correct data entry to LIMSAssessment of testing results generated in the laboratory and close out of batch analysisEnsure that all target dates are met.
Update visibility tools and communicate status of testing at meetingsMaintain laboratories to a high housekeeping standardEnsure high standard of lab records, with work completed Right First Time and on timeWrite and maintain necessary documentation (SOPs, methods, reports etc)Work as part of the team ensuring customer expectations are met and exceeded.
Support achievement of client and SGS Key Performance Indicators, such as around investigations, training, productivity and on-time testingNotify appropriate contact and document results and investigations for any atypical or aberrant resultsLead Laboratory investigations and deviations if requiredMaintenance of a safe working environment, in a state of audit readinessIdentification and implementation of safety, environmental, quality and service improvementsWork with their leader to ensure self-development and progressionQualificationsEducation and training: Science Graduate in Chemistry or equivalent science education (Level 7)Necessary job experience: At least 3 - 4 Years experience in a GMP laboratory.
GMP experience is a minimum requirement for this position.Professional requirements: Demonstrated Experience with current Good Manufacturing Practices, Data Integrity and sound knowledge of analytical technologies (HPLC, GC, KF, IR, PSD, Xray, Wet chemistry)Good organizational skills and strong communication – written and verbalTeam player, flexible to evolving needs with a strong customer service mentalityExcellent quality and safety standardsAptitude in lab computer systems, including LIMS and Trackwise