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Introduction
This role is involved in the development, qualification and implementation of secondary and tertiary packaging components in the scope of product launch, life cycle management.
Assess, develop, design, specify, test and implement packaging concepts at internal manufacturing packaging site.
Additional responsibilities include assisting or leading in package trial runs, project start-ups, resolving manufacturing issues, supporting continuous improvement projects and labeling development activities. In addition, support change control, non-conformances and CAPA activities working with Quality and Labeling Operations.
Accountabilities
Assist in the introduction of new or revised packaging components by:
- Characterizing secondary and/or tertiary packaging components
- Selection, testing and maintenance of packaging specifications
- Authoring and executing material qualification protocols and reports
- Working with sites to qualify packaging in the equipment and/or processes
- Performing and coordinating with sites for package testing related to package qualification activities
- Write, develop and approve packaging documentation to support all GMP packaging and labeling activities
- Consults with purchasing, production and quality departments to determine costs and feasibility of the proposed packaging
Assist in identification and implementation of programs to improve the quality and/or efficiency of commercial packaging operations by:
- Providing technical support to quality, manufacturing/packaging operations, supplier relations management
- Assisting in various duties to support department, such as Change Requests, Deviations, CAPA, department initiatives, learning activities and various operational improvement programs
Support or represent Packaging Engineering on development and commercialization teams as appropriate by interfacing with Regulatory, Marketing, Product Strategy Leaders, Global Labeling Operations and other internal or external customers on new and existing products introductions to:
- Ensure products conform to regulatory and compliance obligations (e.g. FDA, EMA, DEA, cGMP, etc.).
- Assist in preparation of the Packaging Sections of Regulatory submissions (Common Technical Dossiers or CMC filing). When necessary, participate in plant based government and corporate compliance inspections and audits
- Provide technical form, fit, function review and approval into Takeda Artwork Management system
Support artwork development in the scope of product life cycle management and new regulations by:
- Serving as technical expert for all aspects of packaging development
- Providing the configuration and the associated technical profiles and ensuring their compliance to the established requirements
- Assessing the impact to the Bill Of Material and revising the technical information
- Changing and/or developing new profiles in Takeda system to ensure artwork is developed correctly
- Checking the developed artworks and ensuring their compliance to the technical criteria requirements.
Votre profil
Education and Experience Requirements :
- Bachelor’s degree with minimum 5 years related experience in a regulated packaging operations environment.
- Packaging Engineering degree or experience.
- Experience in working in Biopharmaceutical or highly regulated and compliance industry.
Key Skills, Abilities, and Competencies:
- Complete, in-depth understanding of all aspects of packaging development.
- Embraces change, challenges status quo and makes recommendations for improvements to products and processes.
- Strong interpersonal skills and be able to work effectively and efficiently in a team environment.
- Experience with Change Management in a GMP environment
- Knowledge of packaging standard (ISTA 2A, ISTA 7D, ISO 11607…)
- Embraces change, challenges status quo and makes recommendations for improvements to products and processes.
Complexity and Problem Solving:
- Resolve issues and support manufacturing in day to day activities by performing blue belts or small workshop.
- Capable of acquiring knowledge and applying problem-solving methodologies.
- Proficiency in negotiations and technical problem solving is required to interact with various departments, divisions, and vendors to resolve issues and achieve goals.
- Creates tools that help simplify job tasks and shares or implements these with other.
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