Senior Officer

Purpose This candidate will primarily be responsible for Packaging Development activities for pharmaceutical products for regulated & RoW market (Replacement of one Sr Officer in Packaging Development) Position / Job Title Sr. Officer – Packaging Development, R&D Department Packaging Development Reporting To Manager & Sr Executive Location Thane Years of Experience About 2-3 years. Dosage Form Solid Oral / Liquid/ Nasal

Job Responsibilities / Deliverables

Technical Knowledge: (material & machine)

Development of Suitable Primary packaging system for Solid oral, Liquid oral, Ophthalmic, Nasal product for US & RoW market – Bottle pack, Blister pack
Analysis and Characterization of Reference Drug Product
Preparation of Tradress of innovator/RLD vs own product packaging
Preparation of Specification of Primary, Secondary & Tertiary Packaging Materials
Testing of Primary and Secondary packaging materials as per US & EU Pharmacopoeia
Conduct transport worthiness trials in-house & at external facility
Testing of packaging materials in-house & from external agency
Perform machine trials along with production team for implementation of new packaging, resolving & fixing shop floor problems & market complaints related to packaging, printing etc.
Evaluate the technical documents (TDS, CoA, Tech drawing, layout, Specification & related documents) for different packaging materials
Develop change part in co-ordination with machine manufacture and evaluation of the same for machinability.

Documentation Skills

Preparation of Budget documents (MB0, MB1, MB2)
Preparation of Master Packing Card, BoM, Packaging testing & Trial Protocols
Checking artworks as per machinability & regulatory compliances of respective countries
Preparation of Batch Split document

Teamwork And Coordination

Co-ordination for preparing Artworks for different printed packaging materials (carton, Label, Foil, leaflet, IFU etc. – New Filing & Deficiencies for US & RoW markets
Co-ordinate & closely work with cross functional team FD, AD, SCM, QC, CQA, QA, plant packing team for smooth execution of packaging development activities to meet timelines.

Behavior Aspects

Capable of mingling & collaborative with internal stakeholders
Capable for effective communication & Proactive approach.
Should have Positive attitude of making the activities completed in advance.