About the Company Our client is one of the world’s leading global pharmaceutical manufacturers and suppliers of pharmaceutical related products for the local and overseas global market. Due to new project requirements, our client is now seeking an Laboratory Instrumentation Specialist to be responsible for performing testing and reviewing and writing qualification documentation for a range of instrumentation. About the Role Key accountabilities include the following: Work with computerised lab equipment to assess data analysis and data storage for each instrument. Assess laboratory systems & software to ensure compliance with Data Integrity (DI) guidelines. Write & review qualification documentation & execute documents in accordance with regulatory guidelines & standards. Be responsible for SOPs, validation protocols and technical documents in relation to qualification and lifecycle management. Perform testing & review test results of the system in accordance with regulatory guidelines & standards. About you You will be a self-starter with the following skills and experience: Tertiary qualifications in Science, IT or Computer Systems. Expertise with laboratory instruments & equipment & troubleshooting skills. Experience in laboratory within a pharmaceutical environment. Compliance experience with cGMP, GLP, GxP and Laboratory quality systems & requirements. Knowledge of GMP regulations, documentation & laboratory practices. Computerised based laboratory software such as Empower, Agilent. Culture & Benefits This Opportunity requires an individual with sound laboratory instrumentation background and an understanding of computerised laboratory software to join a leading pharmaceutical organisation. How To Apply To apply for this role, please click the APPLY NOW button. For a confidential discussion on this opportunity, please call Sue Campbell on 1300 793 994 or Maria Julienne on 0491 694 371. PLEASE SUBMIT MS WORD DOCUMENTS ONLY NB: Only shortlisted candidates will be contacted.
