Job Description

: * Administration of LIMS Portfolio * Management of LIMS / LIMSlink / Business Objects trainings * Develop and Review of LIMS / LIMSlink / Business Objects and their related documents such as SOPs / Exceptions / Protocols / : Administration of LIMS Portfolio Management of LIMS / LIMSlink / Business Objects trainings Develop and Review of LIMS / LIMSlink / Business Objects and their related documents such as SOPs / Exceptions / Protocols / Reports etc. Administration of LIMS Template Maintenance and Instance Data Amendments Development and Administration of LIMSlink methods and Business Objects Reports Main Contact as System and Business Expert to assist Global Team and Local Team Identify and Resolve data quality issues Work with QC Supervisors to develop a system based approach on Real Time trending of QC results. Implement and maintain Real Time trending of QC results to acquire early knowledge within QC Local Test Experts so as to provide site with continuous production surveillance capability. Develop into QC Computer System Validation (CSV) Expert. Overall responsible for the roll out of Global QC LIMS program (eg: LABWARE and MODA-EM) QC Coordinator for C3ME / RAM Overall responsible for the QC C3ME/RAM system coordination with site Engineering C3ME coordinators, internal QC C3ME working team and 3rd party contractors on Asset Management (AM). Responsible in training and advising new C3ME working team members in ensuring monthly Work Orders are closed timely with their respective teams. Point of contact for site Engineering C3ME in ensuring current and future Work Orders forecast to Engineering schedules are planned in accordance to QC schedule. Work with site Engineering C3ME coordinator to meet site C3ME objectives. Owner for QC C3ME metrics. QC System Administrator Responsible on User access setup, methods and/or template creation for QC Analytical Instruments. Assist in routine instrument preventive maintenance and calibration activities. Lead and Drive Continuous Improvement (CI) culture Develop and Drive Lean Laboratory Initiatives and Lead Right First Time within QC with site CI lead. Requirements Min Bachelor Degree in Biotechnology, Microbiology, Pharmacy or equivalent At least 3 to 5 years of experience in Pharmaceutical, Biopharmaceutical or related manufacturing environment. Demonstrated strong project management capability and ability to lead multiple projects Demonstrated ability to collaborate with cross functional or cross sites to achieve objectives. For interested candidates, please send your most recent and updated resume to [HIDDEN TEXT] Subject heading: QC Specialist Michelle Lee Ser Min Recruit Express Pte Ltd (R1440070) EA Licence No. 99C4599 If you meet the requirements of this role, please email a detailed resume in Word document to Michelle Lee Ser Min. CEI Registration No.: R1440070 Email: [HIDDEN TEXT] Tel: 67363280 .All information will be treated with strictest confidence. We regret that only short-listed applicants will be notified.