Quality Assurance Specialist
Location: BelgiumSIRE Life Sciences® is the market leader in life science recruitment. We believe the recruitment market needs to gear up in technology and continues innovation. We like technology, in a life science 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!
THE COMPANY
Our client is a professional Pharmaceutical organization, based in Brussel Belgium.
An international company committed to supporting customers. The client has excessive experience, we deliver quality medicines and vaccines, complemented by diagnostic products and genetic tests and supported by a range of services. We are working every day to better understand and address the real-world challenges.
ROLE DESCRIPTION
Your main responsibility will be that you are accountable for a large section of the procedural framework and be responsible for ensuring that GDP and similar requirements are adequately described. Furthermore, you will be responsible for the implementation, improvement and design projects related to the procedural framework for GMP/GDP and business processes for the global distribution. Last, but not least, you will report back to de Global Quality Sytem Lead within the Global Quality Organization.
RESPONSIBILITIES
- Assure the compliance of the GDP/GMP regulation
- Oversee detailed process development
- Lead and participate in departmental process
- Supports Quality Assessments/ audits against Quality Standards working towards inspection preparations
- Qualification/Validation
- GDP Quality Assurance and Regulatory Compliance
- Training capability center and training program development and implementation
- Continuously seeks opportunities to improve existing systems, processes and performance within distribution hubs and local market logistics service providers
- Maintains good working relationships with other departments to reach the same goal
REQUIREMENTS
- Degree in supply chain, scientific or health related field of study
- 5-7 years of experience in pharma / biotech / animal health industry and good understanding of GMP/GDP requirements
- Ability to lead, facilitate, influence and negotiate
- Strong knowledge of Quality Management System processes and/or manufacturing processes
- Able to work independently and also in a team
- Technical writing skills in English, any other language is an asset
- Ability to analyze data and synthesize to investigate and make data driven decisions and CAPA
- Great attention to detail and high degree of accuracy in task execution and GMP documentation
Are you interested and do want to apply for this role, please fill out your application via the apply button below and contact Laura Hoekstra.
