Quality Assurance Engineer – Pharma

Permanent contract

Poggibonsi

11/05/2021

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Reference number

2021-20328

Category

Operations — Engineering/production

Business industry

Life sciences

Minimum level of experience required

5 to 10 years

Location

Toscana, Italy

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Job description

AKKA ranks as the European leader in engineering consulting and R&D services in the mobility sector. As an innovation accelerator for its clients, AKKA supports leading industry players in the automotive, telco&media, industrial, aerospace, rail and life-sciences sectors throughout the life cycle of their products with cutting edge digital technologies (AI, ADAS, IoT, Big Data, robotics, embedded computing, machine learning, etc.).

 

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

 

Quality Assurance Engineer - Pharma

 

The resource will lead QA Engineering activities and will be accountable for ensuring Engineering Compliance in projects and routine activities.

 

The main activities include:

 

  • Ensure Compliance of the Engineering requirement of EU GMP
  • Manage Change Control, Deviations and CAPA
  • Prepare and develop Risk Analysis
  • Review/Approve Qualification/Validation Protocols
  • Lead cross-functional teams through each phase of the project
  • Problem solving and Project planning

Profile

The ideal candidate has a Physical Sciences, Engineering Degree or appropriate related field Degree and 8/10 years of experience in the role. Geographical mobility is required at national and international level. Knowledge of the English language is required.

 

Requirements:

 

  • Experience with Change Control and Deviation management
  • Experience with Validation/Qualification activities
  • Experience with Engineering Compliance, GMP and QA support
  • Knowledge of SAP and Trackwise
  • Knowledge of planning and organization
  • Experience within Pharma industries, processes and terminology

 

 

 

Job Offer

Permanent contract

 

 

 

Location

Poggibonsi

 

 

 

Founded in 1984, AKKA has a strong entrepreneurial culture and is pursuing fast-paced growth and international development in line with its strategic plan CLEAR 2022.  The Group continues to recruit at a steady pace to support its strong business growth.  As of 31 December 2020, the Group had 20.000 employees on an international level. Driven by its expertise in future mobility, digital and industry 4.0 technologies, the Group’s 2020 revenues amount to €1.503.5 million.

 

 

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