Compliance Consultant

Compliance Services - United States

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About Arcondis

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.

Open Position

Tasks and responsibilities

  • Active management, support, and delivery of client projects within the compliance area in a regulated environment

  • Consulting clients within the compliance area (CSV, qualification, validation, regulatory affairs & quality management)

  • Customer advice in the conception and implementation of new compliance requirements in the regulated environment as well as the conception and implementation of QMS

  • Equipment qualifications, commissioning, and method validations

  • Preparation of qualification and validation plans for laboratory and production-related processes including method validation

  • Preparation and review of specifications and risk analyses

  • GMP-compliant documentation

  • Planning and execution of qualifications and validations

  • Processing of changes and deviations

  • Creation of Standard Operating Procedures (SOPs)

  • Maintenance and archiving of documents

  • Provide training and ensure training standards

  • Support of pharmaceutical release laboratories in GMP activities

  • Active support in the business development


Your profile

  • BS degree in either pharmaceutical sciences, biotechnology, engineering, chemistry, or computer science

  • 2+ years of practical experience in a pharmaceutical laboratory or production environment

  • 2+ years of practical experience in quality assurance is beneficial

  • Very good GMP knowledge and knowledge of regulatory requirements (FDA, EU, GxP, ISO 13485) and best practices (GAMP5)

  • Professional experience in the qualification (e.g. laboratory equipment, facilities, hardware)

  • Experience in method and process validation (e.g. analytical methods, CSV, etc.)

  • Experience in setting up QMS in the pharmaceutical and/or MedTec environment

  • Experience in SAP R3 / SAP Hana, LIMS or MES environment is an advantage

  • Careful, self-contained, and responsible way of working

  • Excellent verbal & written communication along multiple disciplines 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


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