Qualification/Validation Specialist in GxP

vor 2 Monaten

Frankfurt, Deutschland Global Market Solutions GmbH Vollzeit

GMS is an operational consultancy with expertise in data and digital systems. Whether digitalisation, data & analytics or compliance - our consultants are the missing piece of our customer’s digital puzzle. We empower their ongoing digital transformation and transform challenges into opportunities. We're part of the MoOngy Group, a more than 18 years old European network of companies with a focus on IT & Engineering expertise.

Aufgaben

As a Qualification/Validation Specialist, you will be responsible for ensuring that all equipment, systems, and processes within our GxP-regulated environments are qualified and validated according to industry standards. You will play a key role in maintaining compliance with Good Manufacturing Practices (GMP) and other relevant regulatory guidelines, contributing to the overall success and quality of our operations.

Your tasks as Qualification/Validation Specialist in GxP:

  • Perform Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) for equipment and systems in compliance with GxP guidelines.
  • Conduct process validation and equipment qualification activities to ensure that all manufacturing, laboratory, and IT systems meet regulatory requirements.
  • Develop and review validation protocols, reports, and standard operating procedures (SOPs).
  • Collaborate with cross-functional teams, including Quality Assurance (QA), Engineering, and Production, to ensure smooth validation processes.
  • Perform risk assessments to identify potential risks and implement appropriate controls to mitigate those risks.
  • Maintain thorough documentation of all qualification and validation activities in compliance with GxP standards.
  • Ensure adherence to GAMP 5, GMP, and other relevant regulatory requirements during all validation projects.
  • Support internal and external audits by providing validation documentation and addressing any queries related to validation activities.
  • Monitor and address any deviations, non-conformances, or changes in validated systems and processes.
Qualifikation
  • Bachelor's degree in Chemistry, Biochemistry, Pharmaceutical Sciences, or a related field.
  • 2-3 years of experience in validation and qualification of equipment in a GxP-regulated environment
  • Strong knowledge of GMP, GAMP 5, and other regulatory requirements.
  • Experience with validation documentation, including writing and reviewing validation protocols and reports.
  • Familiarity with risk management tools (e.g., FMEA) and approaches in validation.
  • Ability to work collaboratively in cross-functional teams and manage multiple projects simultaneously.
  • Strong organizational, communication, and problem-solving skills.
  • Attention to detail and a commitment to maintaining high standards of quality and compliance.
  • Prior experience in a German-speaking GxP environment (mandatory)
  • Experience with computer system validation (CSV) and IT system qualifications (is a plus)
  • Native in German (mandatory)
  • Residency in Germany, with the ability to work in a hybrid model from Frankfurt, Rhine-Main Area
Benefits
  • We are a growing company with ambitious targets that stands for expert knowledge, integrity and open-mindedness.
  • As a consultant, you will implement a wide range of projects for our well-known customers and offer them your growing expertise
  • Your development is supported by a coach, further training, our in-house learning platform and an internal IT & data network
  • Work-life balance is important to us - you enjoy home office options, have the choice between regional or Germany-wide projects and our philosophy is a 40-hour week
  • We also offer security and stability - our employees are employed on a permanent basis

At GMS we defend equality and diversity. We create a safe and diverse environment where all the opportunities are equal for all the employees. We do not discriminate based on age, ethnicity, sexual orientation, gender, disability or any factor other than merit. All applications with skills for the position are welcome Would you like to apply with us? Then we look forward to receiving your CV.



GMS ist eine operative Beratung im Bereich Daten und digitale Systeme im regulierten Umfeld mit Schwerpunkt auf der Life Science Branche.

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