Quality Assurance Specialist – Ophthalmic Eye Dropper Bottles

• 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