Maja Smilevska

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Senior Validation Consultant

Ref #: ID: 32083
Maja Smilevska 07/12/2021
Location: Karlsruhe, Germany, Switzerland Not Disclosed Karlsruhe, Germany, Switzerland
Salary: €80,000++ £
Type: Permanent
Seniority: Mid/Senior Level
Specialisms: CSV (Computer System Validation)
Date: 07/12/2021
Senior Validation Consultant

We are looking for a Senior Validation Consultant for the pharmaceutical domain

As Senior Validation Consultant for our client, you are responsible for counselling and validation activities for pharmaceutical equipment, systems, and processes on behalf of our customers.

While our offices are located in Karlsruhe, we support working from remote / from home!

Your role within the team:

  • You counsel and support our well-known pharmaceutical customers with design and execution of their validation activities in a regulated industry
  • You are responsible for quality assurance activities from planning to specification to acceptance of a customer project
  • You perform, coordinate, and support validation and verification activities in customer projects and ensure successful execution
  • You create risk analysis and verification strategies
  • You are responsible for project- and system-specific validation documentation following regulatory needs of the pharmaceutical industry to achieve compliance

Your profile:

  • You hold a scientific or technical bachelor’s or master’s degree (or equivalent qualification)
  • You come with multi-year expertise in computer system validation (CSV)
  • You have experiences in the pharmaceutical domain (e.g. documentation, production, or quality management) with software systems and verification methods
  • You know the requirements, regulations, and guidelines of the pharmaceutical industry (FDA, EU, ICH,…), GAMP 5 best practices, and understand pharmaceutical production processes
  • You are a team player with good communication skills and know how to manage your projects and your schedule
  • You excel at distinct analytical and conceptional competencies
  • You are experienced in dealing with international customers
  • You are willing to travel
  • German language skills are a plus
  • Knowing how to apply traditional and agile validation methods is a plus

Your benefits:

  • Unlimited contracts and flexible working arrangements
  • An innovative job in a national and international environment
  • Exciting challenges and a long-term perspective for personal development in a growing team
  • A state-of-the-art working environment in a highly motivated and professional team
  • Flat hierarchies and a considerate and friendly working atmosphere
  • Very interesting insights into the business world at a variety of our customers
  • Many exciting career opportunities for the future within the Körber Group
  • Attractive and performance-related compensation
  • At the Karlsruhe location: in-house child care, fitness studio
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