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rubicon research limited

Senior Officer

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  • Posted 3 days ago
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Job Description

PurposeThis 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 TitleSr. Officer – Packaging Development, R&DDepartmentPackaging DevelopmentReporting ToManager & Sr ExecutiveLocationThaneYears of ExperienceAbout 2-3 years.Dosage FormSolid Oral / Liquid/ NasalJob 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.

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Job ID: 147251453