QC Scientist

  • Ness Ziona

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about this position

Write SOPs and qualification protocols and reports under GMP requirements

Execution of IPCs and release methods for clinical studies

Responsibility of stability studies including design, protocols, execution and reports

Out of spec investigation with QA CMC

Duties

Requirements

  • BSc/ MSc degree in Life Sciences, Biotechnology engineering or equivalent with a minimum of 3 years of relevant industry experience

  • Advanced knowledge and experience in QC microbiological departments in pharmaceutical industry

  • Experience in working under GMP requirements

  • Experienced in various analytical methods as SDS-PAGE, PCR, ELISA, Microbiological assays etc.

  • Experience in Analytical/Microbiological method validation, including writing of protocols and reports

  • Experience in maintenance of Laboratory equipment. Knowledge and understanding of regulatory requirements for different aspects of drug manufacturing, release criteria and stability requirements in line with ICH and FDA guidelines – an advantage

  • Ability to assess and prioritize multiple tasks, projects and demands

  • Good communication skills and leadership and excellent interpersonal relationships

  • Excellent organizational skills


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