Quality Assurance Specialist – Ophthalmic Eye Dropper Bottles
Sonipat Road, India | Sonipat | Full-time
Job Description
- 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.
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
