Job Description

Company Description

ADAMAS Consulting has been leading the industry for over two decades, conducting audits in all therapeutic areas in over 100 countries. By applying critical thinking to solving compliance issues as pragmatically and efficiently as possible we continuously innovate to meet the challenges of the ever-changing clinical landscape.



This is a pool posting to collect resumes for various auditing opportunities which can be FTE or contract roles in GCP, GVP, GLP, and GCLP auditing.

ADAMAS\xe2\x80\x99s success is down to the caliber of its people \xe2\x80\x93 to reward them we offer a competitive salary with benefits, excellent working conditions and a fulfilling and rewarding career, with plenty of opportunities for further development.

ADAMAS Consulting LLC is an independent provider of GXP Quality Assurance services to the pharmaceutical, biotechnology and healthcare industries. ADAMAS Consulting LLC, established in 2007, is the fully owned US subsidiary of ADAMAS Consulting Group Ltd based in the UK.

Responsibilities:

• Delivery of projects in compliance with agreed project proposals
• Prepare, conduct and report GLP/GcLP system audits for both client and service providers as well as inspection support
• Conduct mock GLP inspections
• Perform the role of Project Lead and Client Liaison
• Project management of audit programs
• Delivery of consultancy services e.g., GLP system reviews, vendors, gap analysis and ad-hoc consultancy

Qualifications

Requirements:

• BS in Life Science, preferred
• Experience in conducting and leading internal and external GLP/GcLP/GCP/GVP audits for a variety of stakeholders (e.g., bioanalytical laboratories, central laboratories)
• Experience in conducting a range of service provider audits
• Experience in coordinating and managing inspection preparation activities for GLP process inspections
• Experience in conducting GLP/GCLP/GVP/GCP mock inspections to Competent Authority standards considered a significant advantage
• Acting as subject matter expert to ensure effective inspection preparation management
• Expert knowledge of national and international GLP/GcLP/GCP/GVP legislation and guidelines
• Proficient in managing projects and ensuring deliverables are provided timeously
• Ability to identify issues and offer solutions in a pragmatic way

Other Requirements:

• Strong communication skills
• Excellent writing skills
• Positivity, flexibility, and adaptability
• Highly professional and self-motivated
• Ability to work independently in a home office setting
• Confidence to work alone or in team
• Up to 40% travel and ability to conduct remote audits

Additional Information

Our people and the way we work set us apart. We work closely with our clients, providing industry-leading innovation and knowledge to deliver solutions that add genuine value to their business.

We place great worth on development and collaboration so we can best succeed together. When needed we also place great importance on intellectual curiosity and the ability to work autonomously.

Adamas Consulting