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12 days old

GLP Auditor

Kelly Services
Raleigh, NC 27608
**Kelly is actively recruiting for Direct Hire GCP Auditor position within the Pharmaceutical Industry.**


To provide professional, high caliber quality assurance and quality management services to the pharmaceutical industry. Duties will be carried out in accordance within the Quality Management System (QMS).


**General Responsibilities**


+ Perform projects which fall within the job holders areas of expertise (GLP and GcLP) on behalf of client companies within the pharmaceutical industry

+ Actively participate in the Clients Learning and Development System

+ Perform other reasonable duties as requested by the job holders Line Manager


**Projects**


This may include audits, preparation of training material and delivery of training, development of QMS/Standard Operating Procedures (SOP) and general consultancy. Specific duties may include:


+ Delivery of projects in compliance with agreed project proposals and budgetary constraints

+ Performing the role of Project Lead, Lead Auditor, Client Contact, Co-auditor or Consultant

+ Project management, including project plan preparation, project oversight, and archiving/destruction of project documents

+ Audit management, preparation, conduct, reporting, follow up and archiving/destruction of audit documents

+ Delivery of consultancy services (e.g. SOP development, quality system advice, general advice on regulatory compliance issues)

+ Preparation of training material and training delivery


**Learning and Development**


Consultants must maintain an up to date knowledge of domestic and international regulatory requirements and industry guidelines/best practices governing the pharmaceutical industry as relates to GLP/ GcLP and Bioanalytical Guidance Documents. Advantage should be taken of learning and development opportunities to facilitate increasing competence and achieving the job holders full potential. This will include:


+ Participation in the process whereby knowledge and learning are shared across the organization (i.e., by attending training meetings and presenting when requested)

+ Maintaining competence records to provide evidence that individuals have the necessary education, training, experience, and skills to perform their assigned tasks

+ Attendance at external training courses

+ Participation in on-the job training, this may be either as a trainee or trainer

+ Reading publications and other sources of literature, e.g. regulatory authority websites, CQA Advisor, QUASAR


**Other Duties**


The job holder may be requested to assist with other aspects of the clients activities, including (but not limited to):


+ Projects defined in SMART objectives

+ Non-critical QC of project deliverables

+ Assistance with the Client QMS e.g. QMS document preparation and review, process improvement initiatives, internal and client audits, supplier audit programs


**Why Kelly** **** **?**


Kelly Science & Clinical is your connection to premier scientific and clinical companies looking to hire talented people just like you. Every day, we match science professionals with dream jobs that fit their skills and interestsits the way we think job searching should be. Nearly 100 percent of our science recruiters have a professional background/education in science, so we know a thing or two about the science market and how to get you noticed.


**About Kelly** ****


At Kelly, were always thinking about whats next and advising job seekers on new ways of working to reach their full potential. In fact, were a leading advocate for temporary/nontraditional workstyles, because we believe they allow flexibility and tremendous growth opportunities that enable a better way to work and live (plus, did we mention we provide a ton of benefits ?). Connecting great people with great companies is what we do best, and our employment opportunities span a wide variety of workstyles, skill levels, and industries around the world.


Kelly is an equal opportunity employer committed to employing a diverse workforce, including, but not limited to, minorities, females, individuals with disabilities, protected veterans, sexual orientation, gender identity. Equal Employment Opportunity is The Law. (https://www.dol.gov/ofccp/regs/compliance/posters/ofccpost.htm)
Posted: 2021-04-28 Expires: 2021-05-29

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GLP Auditor

Kelly Services
Raleigh, NC 27608

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