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QA CSV consultant
I'm interested

Industry

Engineering Services

Category

Quality Assurance & Test

Experience

Mid level

Experience

Mid level

Applications are considered on a rolling basis

Location: Multiple locations

Workspace type: Hybrid

Visit website

Contact Person
Chloé Olivet

Job Description

Your role

  • You will give quality assurance oversight on (IQOQ / PQ…) protocols and reports
  • You will help define and support the Validation Approach
  • You will establish procedures for Validation in accordance with international standards (FDA, EMA, ICH, ASTM E2500, GAMP, CFR)
  • You will review CSV specific SOP’S and Templates
  • You will perform risk assessments
  • You will write and approve validation documents (GMP requirements, SOPs, Critical Impact Assessments, …)
  • You will make sure that production practice are aligned with validation conclusion
  • You will communicate to management about issues in the validation process
  • You will attend project meetings
  • You will provide QA oversight and approve deviation
  • You will pro-actively identify potential quality and compliance risks by managing these risks through the risk register and quality plan process
  • You will define validation strategies through the change control process
  • You will write and implement validation documentation (Validation Plan, Validation Summary Report, Risk Assessment, Gap Analysis , Periodic review, ….)
  • You will ensure the correct application of the validation quality systems in the field and define an improvement plan as required
  • You will support the production, QA and technical service teams in the implementation of validation activities
  • You will work in close collaboration with production, engineering, maintenance, QC, QA…

Your profile

  • Master’s degree in (Bio-)engineering, Chemistry, Pharmacy or related scientific domains
  • French or Dutch fluent and fluent in English
  • A minimum relevant experience of 2 years in the (bio)pharmaceutical sector in a computer systems validation role
  • Knowledge of GMP / CFR / Eudralex and the different regulations / standards related to validation activities are a big plus
  • Good interpersonal relationship skills
  • Problem solving and achievement oriented
  • Be a good team player in order to succeed in each validation project
  • Be able to use a risk-based approach for problem solving and prioritization of tasks

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About the company

Since 2020, Capgemini Engineering (formerly Altran) has been an integral part of Capgemini, a global leader in consulting, digital transformation, technology and engineering services. As a part of the Capgemini family and a global leader in engineering and R&D services, we bring the most powerful innovation for Intelligent Industry to the world of tomorrow: on the road, in the air, on the seas, in rail transport, in energy production, in life science, finance and telecommunications. We have more than 52,000 engineers and scientists in over 30 countries. Our mission to develop technology for an inclusive and sustainable future requires one thing above all: human energy! We want to grow. Are you a technology enthusiast, ambitious and would you like to be a part of something big? Are you the ONE for Capgemini Engineering?

I'm interested