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QC System Specialist/Associate
QC System Specialist/AssociateAbbVie • Singapore, Singapore
QC System Specialist / Associate

QC System Specialist / Associate

AbbVie • Singapore, Singapore
11 days ago
Job description

Job 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.

Responsibilities : Team Support

  • Responsible for supporting QC laboratory infrastructure / system needs (e.g. Equipment, Method, QC

Systems) for routine usage.

  • Develops technical competency and jointly creates a great place to work in.
  • Financial Support

  • Supports financial spending are within the latest best estimates.
  • Supports QC infrastructure / technological needs through long range plan execution.
  • Compliance (Quality and Safety)

  • Develops to be SME for QC Operational readiness (E.g. : QC system or method transfer),
  • infrastructure / instrumentation (E.g. : Advance technology) and compliance readiness (Eg : QC System, Lab

    compliance, Data integrity) per cGMP / EHS / Regulatory compliance global or site procedures expectations.

  • Authors lab documentation, method transfer / qualification and equipment qualification (E.g. : Reports, Protocol,
  • change control, related quality documents or procedures) are in cGMP compliance to corporate / site or

    regulatory requirements.

  • Participates or supports in resolution of laboratory investigation / exception or actions for closure.
  • Participates in internal / external audits and enables audit response for a successful outcome in sustaining
  • licenses to operate.

    Infrastructure & Instrumentation

  • Supports 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.

  • Supports QC laboratory long range plan to ensure laboratory infrastructure needs is secured and Data
  • integrity plan is in place to support business and laboratory compliance.

    New Product Introduction, Projects & Continuous Improvement

  • Supports method technology transfer and infrastructure / laboratory equipment technological introduction
  • activities into QC Laboratory within project timeline.

  • Supports CI initiatives to enable laboratory performance metric.
  • Any other task / projects assigned by line manager.
  • Qualifications

  • Bachelors in Sciences (i.e. Biologicals, Biomedical, Chemistry, Life Sciences, Pharmaceutical), Pharmacy, or
  • Engineering (i.e. Biomedical, Chemical, Pharmaceutical), or equivalent
  • Analytical thinking with Simple problem-solving and technical writing skills.
  • Motivated and Independent.
  • Basic GMP knowledge / Experience in laboratory
  • Collaborator with cross functional teams.
  • Able to work towards timeline.
  • Minimum 2 years for Bachelor graduate with relevant work experience in Biotechnology / Pharmaceutical industry is preferred.
  • Additional Information

    AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives and serving our community.  Equal Opportunity Employer / Veterans / Disabled.

    US & Puerto Rico only - to learn more, visit  https : / / www.abbvie.com / join-us / equal-employment-opportunity-employer.html

    US & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more :

    https : / / www.abbvie.com / join-us / reasonable-accommodations.html

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    QC System SpecialistAssociate • Singapore, Singapore

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