QA CMC and Preclinical

Posted 1 month ago

Job Description

  • Ensuring quality test results of analytical and bioanalytical test methods
  • Conducting Internal Audits in the GLP laboratory and CMC departments
  • Supplier qualification including Supplier’s audit
  • Writing and updating standard operating procedures
  • Approve controlled documents as protocol, reports and CoA
  •  Review Calibration records, equipment files
  • Support Validation of Laboratory test methods, equipment and computerized system
  • Provide training to CMC and Preclinical team members
  • Deviation ,CAPA and change control management


  • At least 3 year of experience in pharmaceutical, medical device company – significant advantage
  • requirements; i.e., Good Manufacturing Practice (GMP), Good Laboratory Practice (GLP) and OECD guidelines, Good Documentation Practice (GDP)– required
  • BSc/BA in science- required
  • MSc/MA in science- advantage
  • Computer skills including proficiency in use of Microsoft Word, Excel and PowerPoint
  • Ability to prioritize, self-control and diligence in completing big demanding projects
  • Strong written and verbal communication skills including good command of English language
  • Effective time management and organizational skills
  • Permanent attention to details, accuracy in work
  • Ability to establish and maintain effective working relationships with coworkers, managers and vendors

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