Quality Assurance Specialist – Ophthalmic Eye Dropper Bottles

Job Description

1. 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.
2. 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.
3. Regulatory Compliance:
   • Ensure adherence to US FDA regulations for ophthalmic packaging.
   • Maintain documentation for regulatory audits and inspections.
4. 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.
5. 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.

Qualifications

• 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.

Additional Information

Need Immediate joiner