Compliance Consultant

Compliance Services - United States

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

Mission

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

Studies

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