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• Routine Testing finished products and in-process control samples according to SOP and as per the committed time lines
• Handle quality management system like Deviations and Out of specification results (Phase 1 investigation)
• Writing, review and approval of test results
• Maintain adherence to corporate policies and appropriate regulations through actions and decisions
• Active participation in advanced problem solving, root cause analysis, troubleshooting, interpretation/consultation, verification of quality and test results discussions
• First-line Troubleshooting of laboratory equipment
• Work a shift pattern (24/7)
• MLO+ / HBO / Bachelor degree in analytical chemistry/pharmacy or equivalent experience
• Knowledge and familiarity with the use of Pharmacopoeia methods
• A strong analytical oriented mindset
• Experience with working in a pharmaceutical environment
• Experience with analytical techniques like, UPLC/HPLC, TOC, PSD, etc.
• Good knowledge of Pharmaceutical quality systems and production processes
• Experience & exposure to work in regulatory environment as well as Regulatory Audit like EU cGMP inspection , US-FDA, ANVlSA
• Team player
• Strong can-do mentality
• Results oriented
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