- Conduct VICH-GCP study audits.
- Conduct external audits (e.g. vendors, third parties, etc.)
- Conduct internal audits (e.g. systems, processes, computer system validations, etc.)
- Development and implementation of Clinical QA plans to meet GCP quality standards, policies and procedures.
- Development and maintenance of internal quality management systems (e.g. SOPs, etc.) and participate in training activities.
- Communicate with Sponsor (Clients) QA and clinical teams.
- A life sciences degree
- Minimum 2 years VICH or ICH GCP QA experience
- Excellent verbal, written and listening communications skills
- Proficiency in English
- Organisational skills and attention to detail
- Ability to travel and driving license
- Second language
- Data Management Quality systems experience
QA Manager - País Vasco, España - SDi Digital Group
Descripción
About Argenta
We are in the animal health business, partnering with our global clients in the areas of Research and Development (R&D) and manufacturing to produce pharmaceuticals for both farm and companion animals.
Originally founded in 2006 by a New Zealand chemist, Argenta's vision is to have healthy animals, making it happen together.
Our recipe for success has been our uniqueness in our vision and our people. Argenta now has operations across New Zealand, the United States, Scotland, Germany, and Spain with more than 600 employees globally.
As part of our current expansion, we have an exciting opportunity to be part of Argenta s success and are currently recruiting a Quality Assurance (QA) Manager in clinical research :
About the role :
As a QA Manager you will part of our clinical research team providing all services related to the conduct of multinational veterinary clinical trials for regulatory submission.
The responsibilities of the QA Manager include, but are not limited to, the following :
To be successful in the role, you will have :
Essential :
Desirable :
The position is based in Hondarribia, Gipuzkoa, Spain. However, a hybrid position will be considered for suitably experienced candidates.
If you fit the above requirements and are looking for an exciting career move, we d love to hear from you.
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