![]() (like GMP, GLP, ISO, GDP, GCP) Experience: Four years of experience in (bio)pharmaceutical environment with at least one year in Quality Assurance. Biotechnology, chemistry, biopharmaceutics or equivalent Technical skills: Extensive knowledge of and experience with GMP regulations for EU and US. ![]() Required skills & qualifications in order to be successful in this role: Decisiveness Communicative Responsible Quality oriented Teamwork Problem analysis Behavioral flexibility Knowledge: Education: BSc. Preparing and supporting internal and external audits in relation to applicable guidelines (like GMP, GLP, ISO, GDP, GCP). Identify and communicate areas for improvement. Review, analyze and prepare documentation related to commercial starting material production, including batch records, specifications and certificates to ensure compliance with applicable guidelines and procedures. Organize meetings with BME and/or Pharming departments to ensure problem resolution and conducting investigations associated with deviations, Change Controls, and CAPA’s. Act as co-trainer and expert for other Quality Assurance Officers. Identify documents which need to be created or updated and ensure this is organized. in alignment with applicable GxP guidelines. Areas of responsibilities: Write, implement, review and maintain SOPs, policies and other QA related documentation. ![]() He or she evaluates, analyzes and prepares pharmaceutical related documents needed for batch release and compliance to GMP. About the role: The QA officer ensures that the quality system at Pharming, external partners and contractors is compliant with EU and USA GMP legislation, guidelines and/or Pharming quality expectations. As a result of this growth, we are looking for a Quality Assurance Officer in Leiden. The company is based internationally and growing quickly. The company is poised for further scientific, technological and new product development and additional commercial roll-outs. ![]() Leiden Pharming is a global, commercial stage biopharmaceutical company developing innovative protein replacement therapies and precision medicines for the treatment of rare diseases and unmet medical needs.As a result of this growth, we are looking for a Quality Assurance Officer in Oss. QA Officer Full-time Oss Pharming is a global, commercial stage biopharmaceutical company developing innovative protein replacement therapies and precision medicines for the treatment of rare diseases and unmet medical needs.
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