Qc Science - Singapore - AbbVie

AbbVie
AbbVie
Verified Company
Singapore

2 weeks ago

Wei Jie

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Wei Jie

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Description

Company Description
The primary function is to support management of all QC laboratory systems (E

g:
Equipment, LIMS, CDS, IT related systems), participate in method technology transfer, participate in laboratory equipment technological refresh or introduction is in adherence to cGMP regulatory compliance and corporate/site procedures expectation

  • Supports team task to enable adequate resources to support laboratory infrastructure (E

g:
Equipment, Method, System) need

  • Participates in the management of laboratory equipment and IT systems in QC laboratory to ensure business continuity and system data maintenance, equipment maintenance/calibration is in a state of compliance
  • Participates in method technology transfer and laboratory equipment technological refresh/introduction activities into QC Laboratory within project timeline
  • Participates in QC laboratory long range planning to ensure laboratory infrastructure needs is secured and Data integrity plan is in place to support business and laboratory compliance
  • Author method transfer/qualification and equipment qualification documentation (E

g:
Reports, Protocol, change control, related quality documents or procedures) are in cGMP compliance to corporate/site or regulatory requirements

  • Supports and ensure timely escalation/handling of lab events or related quality actions. (E

g:
NCR, Lab Investigation, CAPA)

  • Supports preparation and participate in internal/external audit, audit responses, to enable a successful audit outcome
  • Participate in EHS, Business Compliance, cGMP and all other compliancerelated matters, where applicable. Lead/supports CI initiatives to enable laboratory performance metrics
  • Carry out any other task as assigned by Supervisor

Qualifications
Education

  • University Degree in Science related discipline (E

g:
Chemistry, biology, pharmaceutical sciences, or equivalent experiences)

Experience

  • Minimum 3 years of pharmaceutical experience in a Quality Control Function
  • Experienced in Regulatory/ Pharmaceutical requirements

Skills:


  • Analytical thinking with basic problem solving and writing skills
  • Motivated and independent
  • Basic GMP knowledge on QC Lab Equipment and Method transfer experience is a
  • Good communication skills and Strong ability to work cross functional teams
  • Ability to work towards timeline
**Additional Information
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