about the job.
Product Customization:
-Gain an understanding of the packaging requirements of each customer and the general usage scenarios including drug/package interactions for each product produced .
-Advise on the selection of appropriate aluminum canisters based on propellants, APIs, and coatings for specific pharmaceutical applications.
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- Develop Specifications for Pharma products
Validation Support:
-Assist in designing and executing validation protocols for canister applications, ensuring products consistently meet regulatory and quality requirements.
Technical responsibilities :
-Serve as the primary technical contact for customers, addressing technical queries and ensuring effective communication between internal teams and external sides including customers , suppliers
-Identify key requirements and oversee technical interactions with suppliers
-Direct responsibility for Homologating (gaining regulatory approval) of new products
- Conduct structured problem-solving measures for non-compliant products .
Data Analysis and Reporting:
-Analyze validation data, generate technical reports, and contribute to the development of scientific marketing materials such as datasheets, whitepapers, and technical posters.
Process Improvement:
-Collaborate with operations and quality teams to refine existing processes and develop robust standard operating procedures (SOPs) tailored to application-specific requirements.
- Participate in FDA , ISO and other needed QA/manufacturing certifications to support product line
Regulatory Support:
-Support regulatory submissions by providing detailed technical documentation and validation reports as needed.
-Participate in technical conferences in the applied fields, Maintain technical competence .
skills and experience required.
-Minimum of 2-3 years’ experience in a technical role within medical or the pharmaceutical packaging design and a related manufacturing industry.
-Prior experience in technical validation and regulatory documentation is highly desirable.
-Must be a fluent English speaker 。
-Master’s Degree or higher in Chemistry, Chemical Engineering, Material Science or other Medical Packaging related science.
-Ability to work independently ,while also serving as an active team player
-Proficiency in : MS office , CAD drafting (3D), Statistical Analysis software