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

   

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