QC Systems Specialist, LIMS/GMP (Contract, Pharma MNC) #HML
- 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.
- 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 email@example.com
Subject heading: QC Specialist
Michelle Lee Ser Min
Recruit Express Pte Ltd
EA Licence No. 99C4599
Healthcare / Pharmaceutical / Life Science / Medical Device
Healthcare - Pharmaceutical / Life Science / Medical Device / Clinical Research / Regulatory Affairs
Contract / Temp
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
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