Combination Products Expert

Job type:
on-site
Start:
02/2015
Duration:
9 Months
From:
Real Staffing
Place:
Switzerland
Date:
02/03/2015
Country:
flag_no Switzerland
project ID:
844796

Warning
This project is archived and not active any more.
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My client, a leader within the pharmaceutical industry, is currently looking for Senior Combination Products specialist.

Start: ASAP
Workload: 1-3 days per week
Duration: 6-9 month
Location: Switzerland

Requirements:
  • BS degree in Life Sciences discipline or Mechanical/Biomedical or Chemical engineering
  • 5-10 years experience in the medical devices industry
  • Experience in device manufacturing
  • Expert level in Design Control in risk management
  • Sound knowledge of Quality Systems Regulations, and Medical Device Directives, ISO 13485:2003 and ISO 14971, 21CFR part 4 and 820
  • Sound knowledge of cGMP and relevant international regulatory requirements
  • Understanding of the biotechnology industry and specifically combination products
  • Expert in CAPA management
  • English speaking - German is a big plus


Task:

In this role you will work in closely with the QA and QC departments regarding the specification settings, deploying design control as well as supplier related CAPA management.

If this role could of interest for you, please send your CV in Word including your hourly rate expectation for immediate consideration