Qualification & Software Validation Specialist (m/f/x)
Negotiable
Darmstadt, Hessen

Specialist (m/f/x) Qualification & Software Validation | Pharmaceuticals | Darmstadt / Mannheim Area

As a Specialist (m/f/x) for qualification and software validation for this exciting chemical and pharmaceutical company, you will be responsible for the hands-on qualification of production facilities. You'll have the opportunity to contribute your own ideas and experiences.

These tasks are waiting for you:

  • Preparing periodic reviews, annual requalification, audit trail reviews for existing pharmaceutical production equipment, such as filling systems for liquids, pure media systems
  • Conduct software validation
  • Compiling URS and conducting risk evaluations in alignment with current GMP requirements
  • Drafting and revising SOPs related to equipment handling and sanitation procedures
  • Generating reports for deviations, managing change control processes, and overseeing CAPA measures
  • Providing support during external audits
  • Playing an active role in enhancing GMP adherence

This completes your profile:

  • Successfully completed studies in natural sciences, pharmaceutical technology, chemical engineering or similar fields
  • Experience in pharmaceutical production and strong knowledge of GMP compliance as well as qualification of systems
  • Experience in preparing recurring periodic assessments for existing systems and conducting audit trail reviews
  • Team-oriented and structured work approach, as well as analytical thinking
  • Very good German and English language skills both written and spoken

What the company offers you:

  • Flat hierarchies with room for your own ideas
  • Full-time position with 37.5 hours/week - Friday is a half working day
  • Hybrid working environment possible
  • Company pension plan
  • Meal allowance
  • On-site parking
  • Corporate benefits

About our client:

Our client is a specialized company in the development and manufacturing of chemical products and pharmaceuticals. The company is known for its quality, innovation, and customer satisfaction, serving customers in various industries worldwide.

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We are a trusted partner for every step from Discovery through to Development. So, no matter where you are in your journey, we're here to help you make a difference. We are a trusted partner for every step from Discovery through to Development. So, no matter where you are in your journey, we're here to help you make a difference.