Advanced / Senior Csv Consultants - German Speaking

vor 1 Woche


Frankfurt am Main, Deutschland NNIT Vollzeit

**Would you like to be part of a fast-growing IT company dedicated to Pharma & Life Sciences? Does your passion lie within ensuring Quality, Compliance, and Validation?**

Take the step with us and join NNIT’s Compliance, Test & Validation team who is one of the leading teams in Europe when it comes to providing services of GxP regulated compliance and IT validation to the Pharmaceutical, Biotechnology, Life Science industry.

We are passionate people building winning teams with our customers. With deep roots in the pharmaceutical industry, we supply services that meet the highest requirements for quality, security, and standardization. In addition to taking responsibility for complex consulting services in large IT development projects, we also provide customers with strategic advice on compliance with regulatory requirements and process improvements of IT systems, ongoing maintenance, and operation.
- Join us in NNIT and make your mark on a fast-growing global IT company_

**You will be part of our Compliance, Test & Validation team**

Globally we are a team of over 120 Consultants working within various areas of compliance in US, EU, and Asia. Locally, in Europe, we are over 40 consultants and work out of offices in 6 different countries.

It is important for us that you continuously develop both personally and professionally. Therefore, we focus on your skills through interesting assignments, relevant professional training, and personal development plans.

**What are you responsible for?**

As a Compliance Consultant at NNIT, you will be working with some of the largest pharmaceutical companies in Europe. Your job is to advise and support these companies in various aspects. These include:

- You will assume independent responsibility for the creation, review and approval of validation and qualification documents
- You will work as part of a team consisting of customers and NNIT employees in challenging and international IT projects in the pharmaceutical industry.
- As a test lead and validation manager, you will assume responsibility in a wide range of areas such as MES/manufacturing, Veeva implementations or cloud solutions.
- Thanks to your expertise and good communication skills, you form a link between the departments (IT, business, QA)
- You develop strategies and implementation solutions for the validation of complex GxP regulated systems.
- You will integrate and guide junior consultants and trainees.
- You will be actively involved in the acquisition of new clients and projects as well as in the development of the company's services.

**What do you bring with you?**
- Strong consultancy mindset - You listen to your customers and encourage them to adopt new perspectives.
- 3+ years of experience as a CSV/CSA Consultant/ IT Engineer in Regulated Industries
- Good knowledge of ISPE GAMP5, FDA CFR 21 Part 11, EU GMP Guide Annex 11
- You are familiar with CSV/CSA, agile methods, and the corresponding tools.
- Expertise in IT Infrastructure Qualification and IT Service Management Procedures
- Ability to work on multiple smaller projects at the same time and properly prioritize actions
- Excellent communication and presentation skills; fluent English and German, both spoken and written.
- You want to contribute to the success of the project through your commitment and embody our corporate culture, which is characterized by team spirit, flexibility and the will to succeed.
- Mobility: depending on the project situation and customers, some business trips must be expected

**What is in it for you?**
- We offer you a performance-related salary, flexible working hours and the opportunity to work from home with the latest technologies for virtual collaboration.
- You can expect a collegial working atmosphere and numerous amenities for your professional and private life (fitness subscription, overtime compensation, home office set-up, and others)
- A dynamic workplace with good working conditions, social activities, team events, and work-life balance
- Statutory paid leave of 20 working days in each calendar year, plus additional 10 granted working days as paid leave
- Inspiring work environment with access to our global network and ample training opportunities
- Flat hierarchies and a working culture based on trust between NNIT colleagues and management
- We offer the opportunity to work in an international, multicultural company with the most significant customers in the life sciences sector
- We want you to grow with us. That's why we support you with targeted further training measures as part of a personnel development concept planned with you, which defines your long-term career goals, is developed by you and your local manager and implemented in your daily work
- With our regular social events and team summits, we strengthen team cohesion and promote personal exchange among each other

**Location**:
Any location in Germany.

**Language**:
English and German

**What’s next?**

**_Together we make a



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