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Job Description• Supports activities to establish and maintain a Microbiology lab in full cGMP-compliance
• Installs lab equipment, performs qualification and validation activities of lab equipment following written protocols
• Conducts and validates necessary test methods or compendia methods in the lab and performs testing under cGMP
• Follows existing procedures and test methods (assays), and perform testing routine activities
• Participates in Laboratory investigations.(after sample testing) Compiles test documents in a complete, accurate and consistent manner to ensure that samples, materials or products and intermediates have been tested, or inspected according to specification and cGMPs.
• Suggests optimizations of test procedures to improve efficiency whenever possible
• Be able to explain, his/her area of work, in health authorities inspections and internal audits
Minimum requirements• Bachelor's Degree or Diploma in Microbiology, Biotechnology, Biological Sciences, Chemistry, or relevant experience
• Minimum 2 years related experience in GMP-regulated industries in Quality Control Microbiology
• Must understand FDA and ex-USA regulatory requirements as well as industry quality systems
• Must have an understanding of pharmaceutical industry trends and practice
• Able to work 12-hour routine shifts