Auditor. GCP + CSV. United States. Home Based Nr ref.: /JOBS.pl Auditor. GCP (Good Clinical Practice) + CSV (Computer System Validation) United States - Nationwide Location. Home Based GxPs Auditor required - Home Based, Anywhere in the USA. Strong GCP Auditing experience - Lead / Solo for Clinical Investigator Sites and Vendors. Additional Auditing experience within - CSV (Computerised System Validation) Seeking an experienced GxPs Auditor with solid and high level experience and knowledge of regulatory requirements and industry guidelines governing global GCP - FDA required Overview: My client is a leading QA Specialist organisation, with true global reach, and a growing team of successful QA professionals working across GxP auditing specialisms with multiple leading clients. As part of their continued growth, they now seek an experienced GxPs GCP and CSV Auditor to work remote home based, and undertake a variety of rewarding and challenging solo audits for multiple Clients and Vendors, including Investigator Sites / CRO's and Laboratories involved in Clinical Research. Requirements: You will already be an experienced GxPs - GCP (Good Clinical Practice) and CSV Auditor, with proven solo auditing experience in the United States (And/Or) internationally for multiple GCP Investigator site and additionally Computer System Validation audits. You will be a proven auditor with at least 4+ years continued GxP and GCP auditing experience in this field. > You will have a proven background within QA of at least 5-6 years to date and will be able to demonstrate the abilities required to work independently and to manage your travel and audit follow up responsibilities. > You will demonstrate the skills required to work effectively and smart to meet deadlines and clients time criterias, and to always demonstrate a strong professional outlook to uphold the high standards and reputation of my client within industry. > Auditing experience will include at least 3+ years working within industry direct (And/Or) additional consulting to industry as a solo/lead GCP (Good Clinical Practice) investigator and vendor site auditor and also demonstrate additional CSV (Computer System Validation) Auditing experience. > Proven additional solo auditing experience of 3+ years within (GCP) Good Clinical Practice (Investigator Sites / Vendors / CRO's) Also required > Additional GxPs audit experience also beneficial - (GLP, GvP or GcLP) Additional Skills / Knowledge Required: * Ideally you will have at least 3+ years experience working independently as a lead/solo GxP (Good Clinical Practice) site investigation auditor to multiple vendors/clients located in the United States or in addition globally * You will be fully experienced in writing full and detailed audit reports, and will be expected to complete these for each vendor/client site audit undertaken. * You will clearly demonstrate a strong work ethic to managing daily tasks and working to tight timelines, ensuring each individual client/vendor CSV (Computer System validation) audit project is completed to the same exemplary high levels and standards every time. Travel Requirements: * You will be available and eligible to travel locally, nationally and international if required, and be comfortable with travelling for approx 50% of the working time. Typical workload will involve spending up to 1 week (including travel) with a client/vendor - Conducting GCP and also CSV audits solo. Following week - Home based, follow up, full reports and preparation for the next audit. This is typically continual on a bi-weekly rotation. Our client, is a renowned leader within full service Quality Assurance GxPs Auditing, and seeks individuals with passion, drive and strong work ethics to complete tasks under own initiative, whilst being part of a great and successful growth team. * Are you a dynamic, motivated and progressive Quality Assurance GxP GCP Auditing professional, seeking greater income security with the scope to work more independently? * Do you enjoy regular travel, working across a broad mixture of projects with a vast range of clients locally, nationally and on occassion international? * Are you looking to break away from a daily office commute with better home life balance? If you are an excellent communicator at all levels, excel in time management, and you are tenacious, professional, independent, hardworking, and have a strong team spirit and desire to work within a growth organisation where you can add real value - Then this may be your ideal next career move within GxP Auditing. Our client has a broad portfolio of clients across the United States, South America, Canada, Europe, APAC and Global. You will be working across a continual broad range of GCP auditing projects. * Travel - Across the US/North America. Potential Worldwide as required * Solid knowledge of international regulatory requirements desired + Industry guidelines governing GCP (Good Clinical Practice), GLP - ICH, EMA and FDA - 21 CFR part 11. EU also advantageous * Ability to assimilate and analyse information rapidly * Life Science Degree minimum. BSc / MSc. PharmD, PhD * Current resident in the United States - Nationwide. * Home Based. Nationwide - With eligibility to travel as required without Visa / travel restrictions * Registrations, accreditations or certifications - Preferred (RQAP-GCP/GLP) Package: Our client offers a competitive salary, generous start holiday allowance, 401K, Healthcare, and provides its consultants the scope to develop their career, together with an exciting portfolio of clients across Pharma, Biotech and CRO's. ** Full Time Employed Position - Home Based ** Regular and Frequent Travel. Local, National, and International. Up to - 50% Contact with your resume today to apply Email: Kontakt: Aplikuj teraz Ogłoszenie pochodzi z serwisu Jobs.pl .
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