Packaging Development - Executive /Sr.Executive/Asst.Manager

Biological E

4 - 9 years

4 - 9 Lacs

shamirpet hyderabad

Posted:3 weeks ago| Platform:

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Skills Required

packaging development injectables medical devices device development

Work Mode

Work from Office

Job Type

Full Time

Job Description

Robust Packaging Design for Drug Device Combination products (Complex Generics Injectable Products) for regulated markets.
Literature research & identifying the right devices for Drug Device Combination Products.
Innovator samples analysis / characterization of packaging components.
Define strategy for Drug Device Combination Products (DDCP) & align all functions of organization.
Coordinate with Manufacturer & develop and execute end to end packaging solutions across all formats of devices including Pen Injectors, Auto-Injector, Syringes and etc.
Ensuring compliance of device regulations as per 21 CFR 820, ISO 11608, 14971, FMEAs, Risk Management/control.
Develop, validate & Implement various packaging analytical laboratory testing equipments and method developments.
Responsible for conducting Device Functionality Tests & generating the documents for regulatory submission of combination products.
Internal procedures (SOP/STP’s & etc.) should aligned as per current standards for Drug Device Combination Products.
Responsible for generating DHF documents for Device products.
Identify & responsible for conducting DVT studies at external labs for Device products.
Responsible for identifying the external labs for Human Factor Studies.
Responsible to provide scientific justification for packaging queries/deficiencies for regulatory authorities.
Handling of troubleshooting for Device Developmental activities related to combination products.
Responsible for Exhibit & other trial batches as per machine and material requirement.
Preparation of Spec’s, STP’s, Trade Dress, BOM’s & necessary documents for device products.
Coordination with all internal stack holders & align the strategy of Device products.
Supporting to regulatory filings of Global markets for Device products.
Technical support to all internal CFT’s for Device products.
Coordination with vendors, design & develop the Device assembling m/c’s / procedures.
Coordination with vendors, design & develop the Device functional test equipment’s.
Timely completion of all internal activities related to Device & meet the project target time lines.

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