Quality Control Technician III
The Quality Control Analytical Laboratory is responsible for all analytical testing to support the production Cytotoxic and Inhalation drug products. The laboratory executes a wide variety of analytical test package to test APIs, excipients, packaging materials and drug products for release and stability purposes. Also transfer, validation and verification of analytical methods for testing of new drug products are performed in the laboratory.
• Routine Testing of the raw materials, primary and printed packaging materials & finished products, stability samples and in-process control samples according to SOP and as per the committed time lines.
• Handle quality management system like Deviations, Out of specification results (Phase 1 investigation), Out of trend results in stability as well as in released products,
• 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
• Active participation in changes or act as change owner as part of continuous improvement.
• 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 development/validation or verification of analytical methods for complex drug products like liposomal or protein coated drugs
• 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
Function Quality Sub Function Manufacturing Quality Control
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