Technical QA Specialist // Noord-Brabant // Permanent position // min. 5 years experience
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 Pharmaceutical organisation, based in Noord-Brabant Netherlands.
- Agree on the validation strategy and provide guidance regarding design, characterization and validation for equipment
- Assure agreed validation strategy is properly documented and aligned with procedural and regulatory requirements
- Provide support to Quality Assurance regarding equipment or information system related production issues.
- Provide quality engineering support to establish appropriate sampling plans
- Act as a 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
- 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
The Company
This 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 Description
In this position you are part of the Quality Assurance team and be the liaison between the quality and engineering. It's your responsibility to ensure new equipment is introduced within manufacturing conforming guidelines and support the engineering team.Responsibilities
Your responsibilities:- Agree on the validation strategy and provide guidance regarding design, characterization and validation for equipment
- Assure agreed validation strategy is properly documented and aligned with procedural and regulatory requirements
- Provide support to Quality Assurance regarding equipment or information system related production issues.
- Provide quality engineering support to establish appropriate sampling plans
- Act as a 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
Requirements
Your profile:- 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 information
We 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?
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