About this 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, BEExperience 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