+ 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
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# About Gerresheimer
Gerresheimer is an innovative system and solution provider and global partner for the pharma, biotech and cosmetics industries. The company offers a comprehensive portfolio of pharmaceutical packaging, drug delivery systems, medical devices and digital solutions. Gerresheimer ensures the safe delivery and reliable administration of drugs to the patient. With around 13,400 employees and over 40 production sites in 16 countries in Europe, America and Asia, Gerresheimer has a global presence and produces locally for regional markets.# Equal Rights
We commit to an inclusive recruitment process and equality of opportunity for all our job applicants. All applicants are considered without any regard to color, creed, religion, gender, gender identity, gender expression, sexual orientation, marital status, veteran status, disability, genetic information, citizenship status or membership, or any other legally protected status. Preference is given to hiring people with disabilities.
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