Quality Manager – GxP (RO)

Location

Timisoara

Experience

Senior
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Active job offers

Quality Manager – GxP (RO)

  • Infrastructure
  • QA
  • Support

Requirements

  • IT infrastructure
  • GxP
  • Quality Management
  • IT Systems/ Services
  • IOQ
  • GxP Audits
  • CAPA Management
  • CSV
  • ISO 9001
  • ISO 20000
  • ISO 27001
  • ISO 13485
  • German language

Job description

Our customer is a German company specializing in comprehensive IT solutions, supporting enterprises in their digital transformation. With extensive experience, it offers high-quality services that include IT infrastructure management, business applications, and modern workplace (Digital Workplace) solutions.

The company focuses on long-term relationships, tailoring services to meet clients’ specific needs, ensuring stability, security, and innovation. They operate throughout Germany, with its primary goal being to help clients achieve long-term success in a dynamic technological landscape.

The company serves a wide range of clients, including large enterprises and organizations with complex IT needs and provides modern IT infrastructures and scalable cloud solutions, such as SAP and AI, customized to clients’ requirements.

 

About the role:

The Quality Manager GxP  acts as IT Quality Assurance to ensure compliance to the before mentioned regulatory aspects locally.

The Quality Manager actively works together with the Governance QM-Team to make sure the GxP -relevant processes are implemented, trained and followed locally.

The person acts as SPOC and IT Subject Matter expert for all local staff regarding GxP-related activities.

 

Main responsibilities

  • Single Point of Contact for all local GxP-related aspects in collaboration within the Quality Management team.
  • Execution of local GxP trainings for staff working on GxP-regulated IT Systems / Services.
  • Ensures that all staff working on GxP-regulated IT Systems / Services are trained adequately before execution.
  • Review of change requests focusing on risk assessments related to GxP-requirements including definition of required documentation.
  • Consulting of local staff regarding GxP-regulated processes (change management, infrastructure qualification activities, etc.) and tool-based processing.
  • Collaboration with QM team to ensure local implementation of GxP-related processes.
  • Review of validation and qualification documentation processed locally (e.g. IOQ test protocols, screenshots) from quality perspective.
  • Managing GxP relevant documentation (e.g. training records, process documents, templates).
  • Supporting internal and external GxP-Audits as well as CAPA Management.

 

Requirements:

  • University Degree in informatics, business engineering or equivalent.
  • Strong technical background in IT infrastructure.
  • Expert in Computer System Validation (CSV)
  • 3-5 years professional experience, working for IT Service Provider
  • Practical experience with validation / qualification of GxP-regulated IT Systems and its infrastructure, ideally in QA functions
  • Familiar with current GxP regulations in CSV, ideally qualification of IT infrastructure
  • Familiar with CSV applications
  • Knowledge in ISO 9001and ISO 20000
  • Ideally knowledge in ISO 27001 and ISO 13485
  • High customer orientation
  • Analytical thinking and structured working methods
  • Language Skills: Fluency in English (spoken and written) is mandatory; German language skills are an advantage.

 

 

 

About Spyrosoft

Spyrosoft is an authentic, cutting-edge software engineering company, established in 2016. In 2021 and 2022, we were among the fastest growing technology companies in Europe, according to the Financial Times. We were founded by a group of tech experts with established backgrounds in software engineering, who created an ‘engineer-to-engineer’ workplace, powered by enthusiasm, fairness and authentic relationships. Having a unique offering, which bridge the gap between technology and business, we specialise in technology solutions for industry 4.0, automotive, geospatial, healthcare & life sciences, employee experience & education and financial services industries.

Benefits

More reasons to work with us

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Yearly training budget

Use your personal training budget to gain new skills and knowledge and continue on the path of self-development.

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Hybrid work

Work from the comfort of your home or any of our amazing offices.

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Work from home or the office

Depending on the position, you can work remotely, from the office or in a hybrid model.

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Internal initiatives

Take part in our knowledge-sharing meetups organised by and for tech enthusiasts.

Recruitment process

It only takes a few steps

Different roles have different requirements, so the recruitment process depends on the specific position you are applying for.

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Checking your CV

We read every resume we receive carefully. If you meet our requirements, we will call you to learn more about your expertise and needs.
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Evaluating your qualifications

After an initial phone call, we check your skills with a task related to your position and provide you with feedback afterwards.
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Making an appointment

The next step is a meeting at our office or online, where you can learn more about the team and our work culture from a Spyrosoft manager and/or partner.
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Getting the answer

At Spyrosoft, we contact every person participating in the recruitment process. Upon acceptance, we will provide a list of the next steps.

Meet the recruiter

Elena Popescu Spyrosoft

I believe that everybody has the potential to achieve success. At Spyrosoft we support you in your professional growth at every stage!

Elena Popescu

Senior Recruitment Specialist

Meet the recruiter

Claudia Lobonea Spyrosoft

It’s up to you to decide what your next step is. At Spyrosoft, you’ll have the chance to thrive and be yourself.

Claudia Neamți

Senior Recruitment Specialist

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Quality Manager – GxP (RO)

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