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Packaging and Device Consultant
Amaris is an independent and international Consulting Group specialized in Management and Technologies.
Amaris operates in over 45 countries delivering services in Business & Management Consulting, IT/Information Systems, Telecommunications & Networking, Engineering, Pharmaceutical & Biotechnology.
Since 2007, the company has grown exponentially and is committed to building lasting relationships with its clients, delivering innovative solutions from project inception to execution.
Tasks and responsibility would typically include:
- Thorough project planning,
- Defining requirements for primary packaging and delivery systems, e.g. drug/device combination products and medical devices,
- Collaborating with internal development partners and stakeholders,
- Delivering assessment on primary packaging materials/processes and oral medical devices in a cross-functional drug product development team,
- Evaluating and challenging technical solutions,
- Supporting and coordinating the manufacturing and supply of packaging material and devices for clinical supplies and production scale-up,
- Supporting a cross-functional project team in the development, review and submission of regulatory dossier,
- Assisting primary packaging Child-Resistance testing activities,
- Contribution to packaging qualification activities at launch sites (blistering, bottling, sachets or stick-packs filling lines,…),
- When applicable, ensuring high quality Design History Files, leading Risk Management activities and supporting Human Factory Engineering activities.
Bachelor’s or Master degree in Packaging Science/Engineering, Materials or Mechanical Engineering or University level Engineering education.
An ideal candidate would have a relevant degree in Packaging Engineering and at least 5 years of experience in a similar area including:
- Good understanding of pharmaceutical development in general,
- Experience in complex projects management,
- Development and documentation of primary packaging, drug/device combination products and medical devices, including GMP, QA and Design Control aspects.
- Packaging process qualification,
- Packaging and device testing (Child Resistance, transport, root cause analysis,…)
- Good technical knowledge in pharmaceutical primary packaging,
- General understanding of Risk Management and Human Factors Engineering.
Fluency in English language is required.
Proficiency in French and/or German advantageous