Quality Assurance Specialist Ophthalmic Eye Dropper Bottles
Gerresheimer · Sonipat · onsite · Posted 48d ago
Not disclosed8–10 yrsfulltimeSourced from
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About this role
Company Description
Gerresheimer is an innovative system and solution provider and global partner for the pharma, biotech and cosmetic industries. The company offers a comprehensive portfolio of pharmaceutical containment solutions, drug delivery systems and medical devices as well as solutions for the health industry. The product range includes digital solutions for therapy support, medication pumps, syringes, pens, auto-injectors, and inhalers as well as vials, ampoules, tablet containers, dropper bottles, other bottles, and more. Gerresheimer ensures the safe delivery and reliable administration of drugs to the patient. With 36 production sites in 16 countries in Europe, America, and Asia, Gerresheimer has a global presence and produces locally for the regional markets.
Job Description
Need Immediate joiner
Gerresheimer is an innovative system and solution provider and global partner for the pharma, biotech and cosmetic industries. The company offers a comprehensive portfolio of pharmaceutical containment solutions, drug delivery systems and medical devices as well as solutions for the health industry. The product range includes digital solutions for therapy support, medication pumps, syringes, pens, auto-injectors, and inhalers as well as vials, ampoules, tablet containers, dropper bottles, other bottles, and more. Gerresheimer ensures the safe delivery and reliable administration of drugs to the patient. With 36 production sites in 16 countries in Europe, America, and Asia, Gerresheimer has a global presence and produces locally for the regional markets.
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.
- 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
Sourced from foundit
Skills
Capping TorqueDropper Insertion ForceSqueeze TestWater Loss TestMaterial Chemical CompatibilityOphthalmic packagingUSFDA RegulationsQuality Assurance TestingRegulatory ComplianceDocumentation
About Gerresheimer
Gerresheimer
Packaging
350
employees
Düsseldorf
DE
₹21.1L PA avg
Avg at Gerresheimer
About
Gerresheimer Glas is a pharma and healthcare producer providing packing products made from plastic and glass. Gerresheimer is a leading global partner to the pharma and healthcare industry. With our specialty glass and plastic products, we contribute to health and well-being. We have worldwide operations and about 10,000 employees manufacture our products in local markets, close to our customers. With our plants in Europe, North America, South America, and Asia, we generate revenues of approximately EUR 1.4 billion. The comprehensive product portfolio includes pharmaceutical packaging and products for the safe, simple administration of medicines: Insulin pens, inhalers, refillable syringes, injection vials, ampoules, bottles and containers for liquid and solid medicines with closure and safety systems as well as packaging for the cosmetics industry.
Industries
PackagingManufacturing
Employee ratings
10 reviews
3.1/ 5
Culture
2.1
Career growth
2.4
Work-life
2.5
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