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QC Systems Specialist, LIMS/GMP (Contract, Pharma MNC) #HML

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 / 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 michelle.lee@recruitexpress.com.sg

Subject heading: QC Specialist 


Michelle Lee Ser Min
Recruit Express Pte Ltd
(R1440070)
EA Licence No. 99C4599


Industry

Healthcare / Pharmaceutical / Life Science / Medical Device


Specialization

Engineering
Healthcare - Pharmaceutical / Life Science / Medical Device / Clinical Research / Regulatory Affairs


Location

North


Employment Type

Contract / Temp


Salary

Negotiable


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: michelle.lee@recruitexpress.com.sg
Tel: 67363280
*All information will be treated with strictest confidence. We regret that only short-listed applicants will be notified.