Job Description

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 healthcare11@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

Administrative Support / Secretarial
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: healthcare11@recruitexpress.com.sg
Tel: 67363280
*All information will be treated with strictest confidence. We regret that only short-listed applicants will be notified.