Group Leader- Packaging Development

Role & responsibilities

Opportunity in our Packaging Development function of Injectable R&D at Bangalore.

The role holder is responsible for the activities related to primary & secondary packaging materials of new development projects

Preferred candidate profile

Candidate with project management and technical skills while partnering with R&D, manufacturing sites, and component suppliers to develop medical device for new product launches for combination product for the export markets.

Identify and develop innovative technologies to meet user needs through an effective balance of internal and external development activities.

Conducting Human Factor/Transportation Study wherever necessary for Pens/Auto Injectors/IV bag/Ophthalmic container etc.

Understanding of functionality testing of PFS, Cartridge, Devices & Bag as per regulatory requirement

Understanding of the regulatory and compliance requirements for combination products as per 21 CFR 820.30, ISO & FDA guidelines for combination products & HF study

Exposure to all ISO guideline required for development of complex injectable i.e; ISO 11040, 14971, 13485,11608, 10993, 15747, 7886 etc.

Support for dossier submission and fulfil of agency queries.

Execution of packaging development activities in alignment with the elements of Design Controls and ensure that all packaging materials/systems comply with departmental and applicable regulatory requirements.

Participating in New Product Development /Packaging Development from conceptualization to commercial production with respect to Packaging design, Device finalization, Functionality, appearance, machines

Create, improve, and maintain Design Control and Quality Management System procedures in collaboration with Quality and Regulatory.

Understanding of EU MDR guidelines

Comprehending technical data and writing drug-device related regulatory documents- Design and Development Plans, Design History Files, Finished Product Risk Assessments, Threshold Analysis, QSR compliance summary documents, FMEAs, Fault tree Analysis, etc.