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QA engineer Pharma Biotech Medical Device
21.07.2019 | Employee | 100%

With over 45'000 consultants around the world and revenue of EUR. 2.9 Bn, the Altran Group is the undisputed global leader in Engineering and R&D services (ER&D).

In Switzerland, Altran employs more than 250 consultants and aims towards large growth with offices located in Zürich, Basel, Lausanne and Geneva.

Altran deploys its expertise particularly in:

- Life Sciences (Pharma, Biotech, and Medical Devices),

- Industry, Aerospace, Automotive, Energy, Railways,

- Financial Services: P&C Insurance, Health Insurance, Reinsurance, Banking

- Telecoms

- Public sector

Our offer
To strengthen our team in Switzerland we are looking for Quality Assurance Consultants.

As a Quality Consultant you will provide our clients with the necessary expertise and assistance to further improve and maintain the quality standards for their operations and products.

 

QA engineer Pharma Biotech Medical Device


Your role


You will be involved in:

- Initiating improvements to the Quality Management System, ensuring compliance to all relevant quality standards and regulatory requirements.
- Handling customer complaints.
- Investigating deviations and non-conformities in cross-functional teams.
- CAPA and risk analysis
- Reviewing batch records and release. 

- Review and proactively assist in process capability studies and statistical techniques as required, to support continuous improvement.

 


Your profile

Education level:

Master or Engineering Degree in quality engineering (EPFL, ETH, HES or equivalent) with emphasis on Pharma- and/or Biotech- and/or Medical Engineering.

 

Requirements:

- Minimum 2 years of experience in Quality Assurance.
- Applied knowledge of FDA or Swissmedic and international Pharmaceutical and or medical device regulations (ISO 13485, 21 CFR 820, etc.).
- Applied technical understanding of manufacturing equipment; processes specific to pharmaceutical, biotech and or medical device manufacturing.


Languages: French and English fluent mandatory.

 


Key qualities:

- You know how to take initiative
- You like to work in a multidisciplinary team
- You value knowledge-sharing
- You must have strong verbal and writing communication capabilities.

 


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