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Senior Subject Matter Expert - Schaffhausen

Eingestellt von Experis AG

Gesuchte Skills: Design, Engineering

Projektbeschreibung

SENIOR SUBJECT MATTER EXPERT - SCHAFFHAUSEN

Looking for a challenging new project within an international environment?

Then we may have the right job for you!

On behalf of our client, one of the biggest players based in Schaffhausen we are looking for aSENIOR SUBJECT MATTER EXPERT within good knowledge of packaging equipment. This is a contracting position, starting in NOVEMBER until THE END OF 2017.

In this position a SENIOR SUBJECT MATTER EXPERT you will be in charge of:

- Design and develop secondary/tertiary packages for optimal equipment and process compatibility
- Collaborate on Packaging and Technical Operations initiatives
- Provide technical input for primary packaging equipment, materials and packages
- Design transfer/technology transfer/commercialization activities including process and equipment qualification (IQ/OQ/PQ).
- Collection of design transfer documentation for consideration within the Design History File
- Review and approve the following packaging documents: packaging component specifications, Packaging Bills Of Materials, Packaging component drawings, design history files, Technical Design Requirements (TDR's), risk/criticality assessment and procedures for bulk and finished drug product.
- Authoring of Technical Development and transfer Plans for Secondary and Tertiary Packaging project
- Preparation and oversight of packaging development activities including preparation and organization of transportation studies.
- Provide support to physical & cold chain shipping studies
- Achieve timely resolution of secondary packaging project

YOUR SKILLS/EXPERIENCES ARE:

- Degree in Mechanical, Biomechanical or Materials Engineering are preferred
- 3+ years experience of packaging engineering and design
- Scientific or engineering expertise with demonstrable results to deliver new products
- Good knowledge of packaging equipment (eg Secondary/Tertiary Material packaging experience )
- Good understanding of cGMP, Good Documentation Practices, and Regulations
- Knowledge of temperature control/cold chain distribution and its application to pharma & medical device
- Working experience with the norms CFR part 3, 4, 210, 211, and 820
- Experience with FDA regulated Design Control, Change Control, CAPA, and ISO 13485
- Project management experience
- Very good communication skilss with Fluently in English. German will be a plus

If you are a result oriented SENIOR SUBJECT MATTER EXPERT currently looking for a challenging new position that applies to your skills, then we look forward to receive your application!

I'm always looking for skilled SUBJECT MATTER EXPERT IN THE PHARMACEUTICAL/MEDICAL DEVICES AREA so please don't hesitate to send me your CV.

Projektdetails

  • Einsatzort:

    Schaffhausen, Schweiz

  • Projektbeginn:

    asap

  • Projektdauer:

    13 months

  • Vertragsart:

    Contract

  • Berufserfahrung:

    Keine Angabe

Geforderte Qualifikationen

Experis AG