Sr. Executive - Packaging & Development - Injectables Medical Device

Role & responsibilities

Responsible for packaging development activities for Development, New Launches, Product Transfers, Pack Changes, Quality improvement projects & design & develop innovative packaging and device concepts to improve the Brand Image and its effectiveness.

Responsible for Packaging and Device development activities start from the product development (Stability Batches), Product Transfers, pack changes, cost improvement projects & Quality improvement projects.

End to end support to stakeholders for selection of suitable cost effective packaging and device materials for products like injectable, Complex injectables and Combination products as per business requirement.

Responsible for characterization of market sample / innovator Pack Analysis on day to day basis.

Execution of Container suitability and generation of reports.

Interacting with Drug Regulatory, PMD, Procurement, Planning, SCM & Business Team to understand market requirement, propose packaging ideas for cost reduction in order to improve product margins.

Preparation of Design control document as per Combination product requirement.

Stability batch coordination, handling FDA deficiencies, Protocol designing & review, Transportation study execution & SAP/eDMS Activities.

Review of Artworks inline with product permission and guidelines and Artwork co-ordination, Print proof and Shade card approvals.

Pack Code creation in CRM.

Preparation of MPR & PM BOM for Exhibit Batch.

Exhibit Batch Coordination, Protocol preparation and MVTR studies and SAP Activities.

Preparation of Primary Packaging Material specifications.

Change part suitability, selection and availability confirmation by coordinating with Plant Production.

Change part development as per Product requirement.

Comprehensive support for regulatory filling with a focus on both packaging and device aspects ensuring compliance and streamlined processes.

Raising of Change control for any revision.

To prepare necessary documents and support for effective technology transfer.

Preparation of SOPs, STPs & GTPs as per the requirement.

Vendor visits for Knowledge gain and Literature Collection.