QA Specialist Validation // Noord-Brabant // Pharmaceutical
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.
• Assure agreed validation strategy is properly documented and aligned with procedural and regulatory requirements
• Provide support to Plant QA regarding equipment or information system related production issues.
• 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
• 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 on a wide variety of projects simultaneously;
• Able to work in a changing environment;
• Fluent in English
The Company
This client is focused on the secondary packaging, the labeling and the distribution of medicines internationally.Role Description
In this position you will be the liaison between the Quality Assurance team and the Engineering team. Therefore we are looking for someone with a strong knowledge of both technic and quality. Your responsibility is to ensure new equipment is introduced within manufacturing conforming the quality guidelines.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 Plant QA regarding equipment or information system related production issues.
• 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
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 on a wide variety of projects simultaneously;
• Able to work in a changing environment;
• Fluent in English
Other information
Do you have the right experience and knowledge to perform this job? Let me know!
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