Executive, Quality Control

Duopharma Biotech – Bandar Baru Bangi, Selangor

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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