Executive, Quality Control

4 hours ago

Bandar Baru Bangi, Selangor, Malaysia Duopharma Biotech Bhd Group of Companies. Full time 90,000 - 120,000 per year

JOB PURPOSE

  • Responsible for the execution of feasibility studies and analytical method activities as per the Analytical Method Validation Plan in accordance with the current industry standards and regulatory requirements.

JOB DESCRIPTION

  • To perform analytical method development and execute a feasibility study of chemical testing procedures to support any new requirements that arise.
  • To assist in analytical method investigation and continuously upgrade methods of testing used in the quality control laboratories.
  • To perform analytical method validation/ verification of analytical method procedures for existing finished products/ API products in accordance with ICH Guideline and PIC/S Guideline.
  • To prepare and review the analytical method documentation i.e. Protocol and report of Analytical Method Validation, feasibility study, etc.
  • To support the method transfer activity and assist in ensuring smooth and successful incorporation of new method and technology transfer into the current QC system.
  • To support the Regulatory Affairs department for product registration i.e. Analytical Method Validation documents.
  • To ensure GMP, GLP, ISO, OSHA, and NIOSH practices are strictly adhered to at all times.

JOB REQUIREMENT

  • Degree or Higher in Science or equivalent.
  • Minimum 2 years of working experience in the pharmaceutical industry.
  • Analytical method development, validation, and research skills.
  • Knowledge of cGMP, PIC/S guidelines, GLP, ISO 9001, ISO/IEC 17025, and operation of laboratory instruments.
  • Knowledge of quality control procedures, related regulatory requirements, and documentation.
  • Good analytical skills and instrument troubleshooting skills.
  • Hands-on experience in scientific equipment and analytical methods.
  • Good understanding of scientific and technical data.

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