Descripción : Due to a constant growth, we are currently looking for a Quality Assurance Specialist with experience in the Injectable area.
Maintain oversight of the QA program and Quality Management System (QMS) at a single SOFIE manufacturing facility producing products under both 21 CFR Part 212 and 211 (as needed) regulations.
Apply quality assurance processes and procedures at the site level to ensure product quality and regulatory compliance.
Write, review, approve, and implement procedures, specifications, processes, and methods as required.
Oversee the examination and evaluation of each lot of incoming material before use to ensure that the material meets its established specifications.
Ensure that components, containers, closures, in-process materials, packaging materials, labeling, and finished dosage forms are examined and approved or rejected to ensure that all these meet their current specifications.
Conduct periodic audits of the site to monitor compliance with established procedures and practices. May infrequently audit another site.
Liaise with internal and external inspectors and representatives, particularly on QA-related topics.
Ensure manufacturing and analytical equipment is appropriately maintained and calibrated. Ensure applicable facility certifications are maintained.
Identify to management problems in personnel, equipment, and the facility that require correction.
Edad máxima para el puesto : 40 años.
Review documents associated with the site’s QA program for completeness, errors, and omissions. Review executed CGMP records and product batch records to ensure compliance and product quality.
Conduct continuous review of aseptic operations to ensure compliance to internal procedures (e.g. gowning, cleaning, sanitation, sterility, environmental monitoring, etc.) and USP / FDA regulations.
Ensure an investigation is performed and documented when required, and corrective and preventative actions are taken (i.
e. follow and maintain corporate CAPA, deviation, and OOS protocols).
Ensure product complaints are handled in a manner consistent with Company SOPs and FDA regulations.
Nivel de estudios mínimo requerido : Licenciado Nivel de Inglés mínimo requerido : Leído : Bueno Escrito : Bueno Hablado : Bueno Experiencia profesional mínima requerida : 3 años Disponibilidad para viajar requerida : El 100% del tiempo laboral
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