Consultant Compliance (Qualification and Validation)

Arcondis Group Published: December 20, 2022
Location
Frankfurt, Germany
Job Type

Description

Arcondis is a global consulting company with an exclusive focus on the healthcare and life science industries, with their particularly demanding requirements on quality and regulatory aspects.

We have been managing challenges and solving problems for our clients in the areas of compliance, business processes, information technology, and digital transformation since 2001.

We create value through cross-functional, sophisticated delivery methodologies and intelligent implementation. Our clients love to work with us because of our unique skillsets, our pragmatic approach, and our will to win.

Your responsibilities / your tasks:

  • Equipment qualifications, commissioning, and method validations
  • Preparation of qualification and validation plans for laboratory and production-related processes
  • Preparation and review of specifications and risk analyses
  • GMP-compliant documentation
  • Planning and execution of IQ-OQ-PQ
  • Processing of changes and deviations
  • Creation of Standard Operating Procedures (SOPs)
  • Maintenance and archiving of documents
  • Ensuring training standards
  • Support of pharmaceutical release laboratories in GMP activities
  • Support in business development

Your profile:

  • Successfully completed scientific or technical studies (for example : Pharmacy, Biotechnology, Engineering, Chemistry)
  • Practical experience in a pharmaceutical laboratory or production environment
  • Very good GMP knowledge and in-depth knowledge of other regulatory requirements
  • Practical experience in quality assurance
  • Professional experience in qualification of laboratory equipment and facilities is an advantage
  • Experience in method validation of analytical methods is an advantage
  • Experience in LIMS or MES environment is an advantage
  • Careful, self-contained, and responsible way of working
  • Very good German and good English language skills as well as strong experience in working with computer systems
  • High degree of quality awareness, strong communication skills and the ability to work in interdisciplinary teams
  • Willingness to travel
  • B-Permit is required!

Benefits:

  • Willingness to continuously improve, grow with new challenges and travel
  • Self-organizing, flat hierarchy
  • Become part of an established company with a start-up mindset
  • Possibility to shape the Arcondis culture and build the team / community
  • Flexible workplace

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