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QC Analyst

2 months ago

Singapore NUSANTARA PRIME CONSULTING PTE. LTD. Full time
Roles & Responsibilities

Responsibilities:

  • Sample storage and management
  • Sample receipt of all routine and non routine samples
  • Perform required benchtop/aseptic aliquoting
  • Perform disposal of respective samples upon batch release. Perform disposal of respective reference samples beyond expiration.
  • Liaise, arrange & perform shipment of required samples.
  • SAP reconciliation check of each batch on the completeness of SAP transaction activities.
  • Preparation of reagents/mobile phase to support analytical testing.
  • Analytical testing (e.g. HPLC) and documentation of API / drug substance / drug product / finished product /
  • Complaints / stability / packaging material samples to cGxP standards
  • Analytical documentation of stability samples to cGxP standards
  • Ensure all activities in compliance with cGxP, incl. data integrity
  • Perform goods receipt for chemicals/reagents/consumables and stored them in respective locations upon receipt.
  • Perform ordering of chemicals/reagents/consumables when it is below minimum order quantity.
  • Perform lab housekeeping activities like glassware washing, general equipment cleaning and lab housekeeping
  • Perform administrative documentation like Files/logbooks archiving, Controlled copy SOPs/logbooks request, Weekly reconciliation check on the CIRF printed documents and Weekly generation of weekly alarm report
  • Comply with all HSE guidelines
  • Detect and report potential accident, risks and propose solutions
  • Responsible for participating in initial training and retraining

About You:

  • Preferred: Previous experience working in a laboratory environment in the pharmaceutical industry (quality assurance, production), aseptic technique.
  • Has completed apprenticeship as a laboratory assistant or equivalent training
  • Collaboration; result-oriented
  • Administrative activities and GMP and HSE-compliant, efficient production and documentation of standardized tasks in the infrastructure
  • Breakthrough Analysis; Being Resilient; Operational Excellence; Continuous Learning; Digital & Tech Savvy
  • Laboratory equipment; Quality Control (QC) Testing; Quality Control Sampling; related industry GxP standards and processes; Laboratory Excellence; Quality decision making

Duration : 12 months. Option to extend/convert subject to performance review.


Tell employers what skills you have

GxP
Pharmaceutical Industry
Sampling
Quality Control
Operational Excellence
Archiving
Quality Assurance
HPLC
Housekeeping
GMP
SAP
Packaging
Decision Making
API
Laboratory