Offers “Akka Technologies”

Expires soon Akka Technologies

Quality Engineer – Pharma

  • ITALY
  • IT development

Job description

Akkodis is a global leader in the engineering and R&D market that is leveraging the power of connected data to accelerate innovation and digital transformation. With a shared passion for technology and talent, 50,000 engineers and digital experts deliver deep cross-sector expertise in 30 countries across North America, EMEA and APAC.

 

Akkodis offers broad industry experience, and strong know-how in key technology sectors such as mobility, software & technology services, robotics, testing, simulations, data security, AI & data analytics.

 

The combined IT and engineering expertise brings a unique end-to-end solution offering, with four service lines – Consulting, Solutions, Talents and Academy – to support clients in rethinking their product development and business processes, improve productivity, minimize time to market and shape a smarter and more sustainable tomorrow.

 

Akkodis is a commercial brand under which both AKKA and Modis entities operate.

 

With a view to strengthening our team, we are looking for a:

 

Quality Engineer - Pharma

 

The Quality Engineer Pharma Product will support the development of finished drug products . The resource will apply technical principles, theories, and new concepts to collaboratively drive the  team from product development to release on market. 

 

The main tasks will be:

 

  •   Definition of supplier pharma requirements  
  •   Definition of applicable standards/regulations  
  •   Definition of Validation and Verification Strategy
  •   CAPA management 
  •   Product/project change
  •   Analysis and product release
  •   Review of Process Validation and risk analysis
  •   Review product and process pharma concepts, testing, evaluates results using appropriate statistical analysis tools

     

    Profile

    The ideal candidate has a Degree in Engineering/Life Sciences discipline  (or equivalent) and 3/5 years of experience  in Medical devices/Drugs/Combination products (finished product) . Geographical mobility is required at national and international level. Knowledge of the English language is required.

     

    Requirements

     

  •   Knowledge of QSR 21 CFR 3, 820, 803 and 21 CFR 4
  •   Knowledge of 21 CFR 210 and 211
  •   Knowledge of design control, change control and risk management
  •   Knowledge of International Guidelines (ISPE, ICH, PDA, EU Ph, USP)
  •   Experience interpreting and implementing US and global medical device/drug/combination products regulation

     

     

    Job Offer

    Permanent contract

     

     

     

    Location

    Modena
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