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stillingsbetegnelse: Senior Packaging Specialist for our R&D team

jobbeskrivelse:

Are you passionate about improving lives of millions of people by developing treatments for skin diseases?

This is your chance to join one of the world’s leading companies within dermatology and to set your mark on the quality of life for millions of patients around the world. Global Research and Development in LEO Pharma devotes its efforts to develop innovative drugs for the treatment of skin diseases like psoriasis and eczema. You can look forward to become part of a team with high professional standards in an informal atmosphere.

 

Team Information

You will be part of a team consisting of five people. You will get highly dedicated colleagues with a broad and varied expertise and experience. The team supports both the development projects from phase I and forward, and the marketed products with Life Cycle Management activities and projects. The team is responsible for finalization and maintenance of the documentation supporting the primary packaging in close collaboration with other departments.

 

Area of responsibility

As new Senior Packaging Specialist, you will be responsible for securing and documenting primary packaging quality during the technical verification phase through to launch and into the product maintenance phase. Your responsibilities will include successful design verification and establishment of regulatory submission documents.

You will have a key role as the primary packaging teams representative in development - and maintenance projects, where you will be in collaboration with drug development and manufacturing partners. It will be your responsibility to establish, review and maintain documentation for regulatory approval of primary packaging.

 

Typical tasks for you will be:

• Development and maintenance of primary packaging for drug products in compliance with current regulatory and GMP requirements and standards securing quality, reliability and launch readiness. 
• Executing technical tasks related to primary packaging development, e.g. materials selection and specification, testing & verification
• Transfer from development into manufacturing and maintenance
• Optimize primary packaging as part of life-cycle management and maintain related documents

 

Our ideal candidate

 

• Has at least 5 years’ experience from working in the industry
• Has solid experience with GMP, regulatory requirements and similar guidelines
• Has worked with physical, chemical and functional tests such as permeability, extractables/leachables, compatibility and tightness
• Is a team player with focus on delivering quality in own tasks
• Is outgoing, tolerant, open-minded and has a pragmatic and solution oriented approach. Poses excellent communication skills (including English), ability to engage with people across the organization
• Feels confident having dialogue with various authorities
• Can take coordination or participate in ad hoc tasks, e.g. root cause investigations and organizational optimization projects (continuous improvements and LEAN)
• Thrives in a dynamic work environment with ambitious colleagues and many projects – and never knowing what the day may bring

 
Next step

For further information please contact Rasmus Ploug Winchler Larsen (+45 31 42 91 70).

Send your application today, as we will invite for interviews ongoing as the applications comes in. 

numberOfPosts: 1

jobCategoriesCodes_0: http://data.europa.eu/esco/isco/C3322

abstractJV_contact_0: Please apply using one of the specified channels

positionTypeCode: directhire

contractTypeCodes_0: fulltime

Arbejdsgiver Navn: LEO PHARMA A/S

source: DK-STAR