Job Detail | GMPGDP Auditor
GMPGDP Auditor U.S. based Contract Clinical Supply and Distribution Company South East – Surrounding Areas
U.S. based Contract Clinical Supply and Distribution Company
South East – Surrounding Areas
50,000 – 60,000 + further company benefits + continued development and progression on a global scale
Are you interested in working for a fast growing Clinical Supply and Distribution company, who will not only value your skills within Quality Assurance, but support you as you grow within your role and the business?
Our client is seeking a highly experienced Quality Assurance Auditor with a strong background in planning, managing and performing audits on a global scale to join them on a permanent basis. It is the intention that this position will responsible of defining, developing, leading and undertaking the audit programme across the companies external suppliers such as third party wholesalers, Depots for re-labelling/re-packaging and distribution, Manufacturers, laboratories and logistics/distribution providers globally.
Within this role you will ensure that all audits are performed in accordance with the companies SOPs, ISO 9001: and cGMP/cGDP.
Responsible for the development, implementation and maintenance of cGDP/cGMP & ISO 9001 compliant SOPs in support of the Quality Management System with regard to supplier Quality Risk Assessment processes.
Contribute to process improvement initiatives across organisation.
Formally report audit observations and agreeing Corrective and Preventative Actions (CAPA) and recommendations with suppliers and monitoring them to completion.
Assisting the procurement teams in identifying and managing suppliers.
Performance monitoring suppliers and responsible for monitoring concerns with them and working closely with them to manage the concerns and develop favourable outcomes.
To provide leadership, training and development of the auditing personnel.
You will have a recognised Auditor/Lead Auditor qualification, an understanding of the clinical trial supply market, effective team working skill sets whilst being self-motivated and driven and be able to build exceptional relationships with colleagues and suppliers.
The successful candidate will work closely with the Global Head of Quality/QP, the President, the Director of Operations, the commercial teams, auditors, suppliers, freight companies and regulatory bodies such as the head of MHRA.
This position will involve travel on both a national and international level within the EMEA and North America
KEY WORDS: QA Quality Assurance Quality Auditor South East Home Counties Kent Regulatory Audit SOP CAPA GMP GDP Audit cGMP cGDP Supplier Clinical Trial Supply Market