Gmp Auditor

Company Description

**Job Description**:
As a GMP Consultant, you will be responsible for planning and conducting GMP audits for our clients in line with the ADAMAS values in quality, integrity, and excellence.

Your responsibilities will include the following:

- Executing audits based on experience and a comprehensive understanding of all federal regulatory requirements and guidance on GMP
- Perform projects which fall within the job holder’s areas of expertise on behalf of client companies within the pharmaceutical, biotechnology, or medical device industry
- Actively participate in the ADAMAS Learning and Development System (LMS)
- Support internal objectives as requested by the job holder’s Line Manager
- Follow ADAMAS Quality Management System policies and procedures
- Maintain positive rapport with clients
- Meet reporting deadlines
- Provide best in class customer service to clients

**Qualifications**:

- Bachelor’s degree in a scientific discipline
- A minimum of 10-15 years of experience within the GMP Pharmaceutical industry in different capacities, i.e., Laboratory, Production, Quality Assurance, Validation, or GMP Consultant
- Highly skilled in technical writing and authoring audit observations
- Highly organized and able to effectively manage a high-volume workload
- Domestic travel 2 times per month for 1-3 days at a time
- Positive interpersonal skills and comfortable interfacing with a wide variety of clients
- Comfortable auditing one or more of the following GMP related services:

- Sterile and Non-Sterile Pharmaceutical Manufacturers (FP, Excipients, APIs, IMPs)
- Cell and Gene Therapy Manufacturers
- Medical Device Manufacturers
- Compounding Pharmacies
- Clinical Supply Management - Primary/Secondary Packaging, Labelling, Storage and Distribution
- Quality Control Laboratory - Microbiological and Analytical

Additional 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 a 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.