R&D QA & Compliance Consultant – Pharma

Permanent contract

Vicenza

08/04/2022

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Reference number

2021-20778

Category

Operations — Engineering/production

Business industry

Life sciences

Minimum level of experience required

1 to 3 years

Location

Vicenza, Veneto, Italy

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Job description

AKKA & Modis are now Akkodis ranks as the European leader in engineering consulting and R&D services in the mobility sector. As an innovation accelerator for its clients, AKKA & Modis are now Akkodis 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:

 

R&D QA & Compliance Consultant – Pharma

 

The resource will support the overall Quality and Compliance activities during the product development life cycle processes, ensuring related practices adhere to market(s) Health Authority regulatory requirements as well as the Corporate GMP Quality Manuals.

 

The main activities include:

 

  • Support Global Product Development (GPD) team in Quality & Compliance, in the process of developing new launches as required by the intended market
  • Support R&D and Product Supply and provide assistance in  project/technology/method transfer to commercial QA/QC
  • Implement, train & maintain Corporate GMP Quality Manual in R&D
  • Review and approve Quality documents, including product specification, batch documentation, test method, analytical validation report, method transfer, equipment qualification and calibration related documents, process validation protocol and reports and packaging documentation
  • Manage QA systems such as Change Control, Planned/Unplanned Deviation, Lab investigations and CAPAs for R&D (Global Product Development)
  • Perform cGMP audit of internal R&D facilities and operations, as well as 3rd Party vendors and follow up with corrective action

Profile

The ideal candidate has a Bachelor of Science in Pharmacy, Chemistry, or other Scientific Disciplines and at least 2 years of experience in the role. Geographical mobility is required at national and international level. Knowledge of the English language is required.

 

Requirements 

 

  • QA and cGMP experience in Pharmaceutical, GMP and regulatory (GxPs) requirements including auditing and inspection against regulatory/quality standards
  • Demonstrated understanding of the best pharmaceutical industry practices, cGMPs, and Quality Assurance and Regulatory

 

 

 

Job Offer

Permanent contract

 

 

 

Location

Vicenza

 

 

Founded in 1984, AKKA & Modis soon to become Akkodis 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 2021, the Group had 21.000 employees on an international level. Driven by its expertise in future mobility, digital and industry 4.0 technologies, the Group’s 2021 revenues amount to €1.553,4 million.

 

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