Validation & Quality Specialist
Location: NetherlandsSIRE® is the market leader in Life Sciences recruitment. We believe the recruitment market needs to gear up in technology and continuous innovation. We like technology, in a Life Sciences market driven on science, we couldn’t stay behind; we drive Recruitment Science. Investing a majority of our turnover in technology enables us to use unique Resource Technologies. By using highly advanced algorithms, we enable our team of Resource & Data Strategists© to maintain the most advanced, detailed and complete Life Sciences network in Europe. This big data enables us to work Reverse Recruitment©: we first analyze the market in-depth before we go out to the market. Because we analyze the whole market, we can compare facts and data. This enables us to do Facts & Big Data Recruitment©, making sure we, or better yet, you find the right career!Our client is a professional Medical Devices organisation, based in Gelderland Netherlands.
• Participation and support for internal and external audits
• Key contact person when it comes to QA departments of multiple clients
• Advisor for ISO 13485, GDP and GMP standards
• Performing CAPA’s and risk assessments for operational and systematical changes
• Bachelor or Master Degree
• Experience in a distribution or warehouse environment
• Excellent knowledge of ISO 13485 and/or GMP standards
• Knowledge of validation and qualification of Medical Devices/ pharmaceutics
• Teamplayer
• Capability to operate with various vertical and horizontal layers within an organisation
• Excellent in English and Dutch
Are you interested and do want to apply for this role, please fill out your application via the apply button below and contact Juliette van Kraaij.
The Company
This client is an innovative and dynamic organisation which is rapidly growing. Currently, they opened a new warehouse which is designed for the re-packaging and distribution of medical and pharmaceutical products.Role Description
In the role as Quality and Validation specialist, you will be responsible for a broad portfolio of validation and QA activities. You will become part of a dedicated and passionate QA team in which you will be supporting the implementation, maintenance and change of the QMS, and validation procedures. You will be in a challenging position as you will have to communicate at several levels within the organization. You will receive the responsibility to make Quality and Validation understandable to all internal and external stakeholders.Responsibilities
On a daily basis you are involved with QA and Validation practices. In addition you will be responsible for:• Participation and support for internal and external audits
• Key contact person when it comes to QA departments of multiple clients
• Advisor for ISO 13485, GDP and GMP standards
• Performing CAPA’s and risk assessments for operational and systematical changes
Requirements
• Minimal 3 years of experience in strongly-regulated environments, preferably Medical Devices or Pharma• Bachelor or Master Degree
• Experience in a distribution or warehouse environment
• Excellent knowledge of ISO 13485 and/or GMP standards
• Knowledge of validation and qualification of Medical Devices/ pharmaceutics
• Teamplayer
• Capability to operate with various vertical and horizontal layers within an organisation
• Excellent in English and Dutch
Are you interested and do want to apply for this role, please fill out your application via the apply button below and contact Juliette van Kraaij.
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