Quality Analyst

The Ophthalmic Eye Dropper Bottles QA position focuses on ensuring the quality and safety of eye dropper bottles utilized for ophthalmic products. Your main responsibilities will include conducting inspections, assessing packaging integrity, executing tests for sterility, leakage, and functionality, as well as ensuring compliance with regulatory standards such as GMP and FDA guidelines. Additionally, you will be responsible for documentation, identifying potential quality issues, and collaborating with cross-functional teams to address concerns. By adhering to quality control processes, you will guarantee that the eye dropper bottles are secure, efficient, and meet industry standards. Your primary tasks will involve: 1) Quality Assurance & Testing: - Validate adherence to quality standards for ophthalmic 3-piece dropper bottles. - Perform and evaluate tests like Water Loss Test, Squeeze Test, Capping Torque, and Dropper Insertion Force. - Evaluate drop size, number of drops, and flow consistency. 2) Material & Chemical Compatibility: - Assess the chemical compatibility of LDPE, HDPE, and PP with ophthalmic formulations. - Collaborate with R&D to study material behavior under various conditions. 3) Regulatory Compliance: - Ensure compliance with US FDA regulations concerning ophthalmic packaging. - Maintain documentation for regulatory audits and inspections. 4) Process & Production Understanding: - Supervise ophthalmic 3-piece dropper bottle filling lines and guarantee the implementation of QA processes. - Recognize potential patient challenges related to dropper bottle usability. 5) Continuous Improvement & Reporting: - Suggest enhancements in bottle design based on test outcomes and patient usability feedback. - Record findings and create reports for management and regulatory purposes. Qualifications & Skills: - Bachelor's/Masters degree in Packaging, BPharma, BSc, BE - Experience in ophthalmic dropper bottles and familiarity with 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. - Proficiency in ophthalmic bottle filling lines and understanding patient challenges. - Strong analytical and documentation capabilities. - Ability to collaborate effectively with R&D, Production, and Regulatory teams. Experience Required: - Minimum of 8-10 years in QA for ophthalmic packaging or related industries. - Previous experience in pharmaceutical packaging QA is advantageous.,