QA Specialist / Noord-Brabant / Permanent position / min. 5 years experience
Opis stanowiska pracy
SIRE® 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 Pharmaceutical organisation, based in Noord-Brabant Netherlands.
The CompanyThis organization is one of the largest pharmaceutical companies in the Netherlands with a specialization in secondary packaging, distribution and labeling. They work with high standards in an international atmosphere.
Role DescriptionWithin this position you will work in a QA team of 5 persons and be the liaison between the quality and engineering. In this role you need to ensure new equipment is introduced within manufacturing conforming guidelines. The team keeps oversight on introduction and modification of equipment, information systems and packaging configurations for commercial secondary packaging operations. By controlling the critical aspect of our operations and systems throughout the life cycle, they safeguard the high quality of the medicines. Additionally, they provide quality engineering support for quality investigations and testing strategies.
Responsibilities- Agree on the validation strategy and provide guidance regarding design, characterization and validation for equipment and information systems in cooperation with the other departments;
- Assure agreed validation strategy is properly documented and aligned with procedural and regulatory requirements by reviewing and approving validation documentation;
- Provide support to Plant QA regarding equipment or information system related production issues. You provide quality engineering support to establish appropriate sampling plans and acceptance criteria;
- Project team member to develop efficient quality processes and translate them in standard operating procedures;
- Perform final review of technical change controls, confirming assessments of different stakeholders are complete and all tasks are correctly represented in the record.
Requirements- Master degree in engineering or pharma;
- At least 5 years of professional experience within a GMP environment
- Relevant experience with equipment and automation validation
- Knowledge of the Quality Assurance principles
- Able to work in complex projects
- Able to communicate with all kind of stakeholders
Other informationWe offer you a great opportunity to be part of the growing company, work on your own development, whilst making sure our medicines find their way to the patients who need them. Sounds interesting?
Are you interested and do want to apply for this role, please fill out your application via the apply button below and contact Ria Bos.
SIRE 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. Rozwiń
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