Quality Assurance Specialist - Ophthalmic Eye Dropper Bottles

About the role

Quality Assurance & Testing: Ensure compliance with quality standards for ophthalmic 3-piece dropper bottles. Conduct and evaluate tests such as Water Loss Test, Squeeze Test, Capping Torque, and Dropper Insertion Force. Assess drop size, number of drops, and flow consistency. Material & Chemical Compatibility: Evaluate the chemical compatibility of LDPE, HDPE, and PP with ophthalmic formulations. Work closely with R&D to analyze material behavior under different conditions. Regulatory Compliance: Ensure adherence to US FDA regulations for ophthalmic packaging. Maintain documentation for regulatory audits and inspections. Process & Production Understanding: Oversee ophthalmic 3-piece dropper bottle filling lines and ensure QA processes are in place. Identify potential patient challenges related to dropper bottle usability. Continuous Improvement & Reporting: Propose improvements in bottle design based on test results and patient usability feedback. Document findings and generate reports for management and regulatory compliance. Bachelor's/Master's degree in Packaging, BPharma, BSc, BE Experience in ophthalmic dropper bottles and knowledge of drop size measurement and compatibility testing . Understanding of US FDA ophthalmic packaging regulations . Knowledge of QA testing for ophthalmic packaging , including Water Loss Test, Squeeze Test, Torque Testing, and Insertion Force. Familiarity with ophthalmic bottle filling lines and patient challenges. Strong analytical and documentation skills. Ability to collaborate with R&D, Production, and Regulatory teams. Experience Required: Minimum 8 -10 years in QA for ophthalmic packaging or related industries. Prior experience in pharmaceutical packaging QA is a plus. Need Immediate joiner

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Company Intel

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