Senior QA 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 Pharmaceutical organisation, based in Zuid-Holland Netherlands.
development data, approves quality documentation and supports activities related to regulatory submissions and inspections. Uses intrinsic quality to interact with stakeholders and support the site’s overall quality level.
• Preferably lead auditor for GMP manufacturing for sterile manufacturing and fill finish activities.
• Serves as the primary quality assurance contact for internal and external business partners and contractors.
• Responsible for QA review of vaccines drug substance manufacturing and qualification and validation projects
• Focuses on technical issues relative to interpretation of policies, compliance and current industry standard.
• Serves a project leadership role as well as assists or participates in special quality projects like the implementation of Intrinsic Quality.
• Maintains and interprets KPI’s and takes measures to improve.
• Effective stake holder management. Contact person for production, analytical and technical global quality initiatives.
• Challenges the status-quo. Involved in conception of new ideas with respect to production, analytical and technical quality processes.
• Languages: English, Dutch is recommended
• (6-8) years QA experience, content knowledge, can be a QP
Are you interested and do want to apply for this role, please fill out your application via the apply button below and contact Ravi Ramnarain Singh.
The Company
.Role Description
The Senior QA Associate provides support for special quality projects and is the process owner for several quality processes. Performs in various quality functional areas and maintains expertise. He/she enforces quality requirements, establishes quality systems for new technologies, reviewsdevelopment data, approves quality documentation and supports activities related to regulatory submissions and inspections. Uses intrinsic quality to interact with stakeholders and support the site’s overall quality level.
Responsibilities
• Serves as a dedicated quality representative on project teams responsible for design and development of drug products.• Preferably lead auditor for GMP manufacturing for sterile manufacturing and fill finish activities.
• Serves as the primary quality assurance contact for internal and external business partners and contractors.
• Responsible for QA review of vaccines drug substance manufacturing and qualification and validation projects
• Focuses on technical issues relative to interpretation of policies, compliance and current industry standard.
• Serves a project leadership role as well as assists or participates in special quality projects like the implementation of Intrinsic Quality.
• Maintains and interprets KPI’s and takes measures to improve.
• Effective stake holder management. Contact person for production, analytical and technical global quality initiatives.
• Challenges the status-quo. Involved in conception of new ideas with respect to production, analytical and technical quality processes.
Requirements
• MSc in a relevant discipline, like biomedical sciences, (medical) biology or life sciences• Languages: English, Dutch is recommended
• (6-8) years QA experience, content knowledge, can be a QP
Other information
Pro-active, agile, and enjoys working in a team. Good organizational and communication skills, creativity, problem-solving capabilities and a process-thinking mindset are key for this position.Are you interested and do want to apply for this role, please fill out your application via the apply button below and contact Ravi Ramnarain Singh.
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