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QC Chemist

Job description

JOB RESPONSIBILITIES:

  • Conduct chemical and physical laboratory tests under minimal supervisor.
  • Complete all testing in a timely manner that supports established production targets and SLAs.
  • Maintain data integrity and ensure compliance with FDA, GLP, QSR and cGMP regulations, as well as with company SOPs and specifications.
  • Observe established escalation process for laboratory issues that impact established production-related Service Level Agreements (SLAs) and/or the fulfilment of production goals.
  • Participate in investigations and root cause analysis.
  • Author documents that ensure cGMP compliance, such as laboratory investigation, deviations, change controls, change notices, analytical test methods, method development/validation protocols and reports and method verification protocols and reports.
  • Seek process innovation and continuous process improvement and perform quality improvement initiatives in the laboratory to meet site production goals.
  • Recognize and report to immediate supervisor any issues or deviations from accepted standards.
  • Provide status updates on own activities and productivity challenges according to defined procedures.
  • Complete and conform to all training requirements for job role, including company-required and job role-specific training.
  • Carry out and assist in the ongoing training of new and existing personnel, as appropriate.
  • Observe all safety and compliance procedures and actively highlight any safety concerns to help drive the reduction of accidents or near misses.
  • May participate in department initiatives and projects.

Requirements;

  • Minimum of a Bachelor’s Degree qualification in Chemistry or related Science.
  • Minimum 2 years relevant laboratory experience in a cGMP environment.
  • Demonstrate knowledge of cGMP requirements and practices including knowledge of the USP and FDA Guidance Documents relating to the pharmaceutical Quality Control Laboratory.
  • Demonstrate analytical competency in the use and troubleshooting/maintenance of common analytical instrumentation e.g. HPLC/UPLC, Dissolution, GC, FTIR, UV/Vis.

 

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