QC Scientist

Ness Ziona · Full-time

About The 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

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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