(Senior) QA Associate farma Leiden (LabResource)

At our client Janssen Vaccines & prevention an interesting position has opened up for a (senior) QA Associate. 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, reviews 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. Key responsibilities: o Serves as a dedicated quality representative on project teams responsible for design and development of drug products. o Preferably lead auditor for GMP manufacturing for sterile manufacturing and fill finish activities. o Serves as the primary quality assurance contact for internal and external business partners and contractors. o Responsible for QA review of vaccines drug substance manufacturing and qualification and validation projects o Focuses on technical issues relative to interpretation of policies, compliance and current industry standard. o Serves a project leadership role as well as assists or participates in special quality projects like the implementation of Intrinsic Quality. o Maintains and interprets KPI`s and takes measures to improve. o Effective stake holder management. Contact person for production, analytical and technical global quality initiatives. o Challenges the status-quo. Involved in conception of new ideas with respect to production, analytical and technical quality processes. For this position we are looking for a professional with the following background: Minimally MSc in a relevant discipline, like biomedical sciences, (medical) biology or life sciences. 3-8 years of QA experience, more senior candidates are encouraged to apply Content knowledge of QA processes in farma Good organizational and communication skills (English required, Dutch is a plus) Creativity, problem-solving capabilities and a process-thinking mindset are key for this position. Dutch working permit is requiredJanssen Vaccines & Prevention is a global vaccine company that focuses on the development, production and marketing of vaccines and recombinant proteins to prevent and combat infectious and other diseases. LabResource is their top-tier supplier and contracted to recruit for this position.Consultant name: Arne van der MeerConsultant phone: +31204069750