Quality Assurance Specialist
hace 14 horas
Overview Actual Talent is the talent acquisition consultancy that offers Executive Search, RPO and Talent Solutions.Inscríbase sin demora Se espera un gran volumen de solicitantes para el puesto que se detalla a continuación, no espere para enviar su CV.Our purpose is to drive the growth and fulfillment of individuals and organizations.We facilitate individuals in finding inspiring opportunities and help organizations discover professionals who will take them to the next level.We do this through talent acquisition and development solutions that focus on people, diversity and inclusion, innovation, and cutting-edge technology.Our client is looking for a strategic QA Specialist to oversee and elevate the quality standards of their external manufacturing network.In this role, you will be the primary Quality point of contact for Contract Manufacturing Organizations (CMOs), ensuring that every drug product is manufactured, tested, and released in total alignment with GMP, GDP, and ICH guidelines.Your work will directly impact the safety and compliance of medicinal products throughout their entire lifecycle.Responsibilities Product Stewardship: Act as the Quality Lead for assigned molecules and finished dosage forms (FDFs), overseeing lifecycle changes, API source updates, and manufacturing process optimizations at external sites.Quality Systems Oversight: Manage and track core QMS processes, including Deviations, Corrective and Preventive Actions (CAPAs), Out of Specification (OOS) investigations, and Change Control management.Technical Documentation: Author, evaluate, and approve critical documents such as Master Batch Records (MBR), Quality Agreements, SOPs, Analytical Methods, and Regulatory Filing dossiers.Validation & Qualification: Lead or review validation strategies (process, cleaning, and transport) and the qualification of facilities, utilities, and equipment.Audits & Compliance: Conduct external audits of suppliers and CMOs.Represent the quality department during Health Authority inspections and third-party audits.Performance Monitoring: Drive the preparation of Product Quality Reviews (PQR) and implement continuous improvement initiatives based on CMO performance data.Technical Support: Provide expert quality guidance for marketed products and lead GMP training sessions for internal teams and partners.Qualifications Academic Background: University degree in Life Sciences (Pharmacy, Chemistry, Biology) or Engineering.A Master’s degree in the Pharmaceutical Industry is highly preferred.Professional Experience: At least 2–5 years of progressive experience within a Quality Assurance department in the pharma sector.Regulatory Expertise: Strong command of GMP/GDP regulations and Quality Management Systems.Technical Tools: Proficiency in SAP, LIMS, and Microsoft Office Suite.Soft Skills: Exceptional analytical mindset, ability to work under pressure, and a proactive attitude toward change and project management.Languages: Full professional proficiency in both English and Spanish.Availability: Willingness to travel occasionally for audits and professional development.#J-18808-Ljbffr
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Quality Assurance
hace 14 horas
Ceuta, España Rephine A tiempo completoJoin Rephine Barcelona: Leading Life Sciences Quality Worldwide. At Rephine, we set the gold standard for quality assurance and GxP compliance in the Life Sciences industry. No espere a enviar su solicitud después de leer esta descripción; se espera un gran volumen de candidaturas para esta oportunidad. With offices in Barcelona, the UK, India, and China,...
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Quality Assurance
hace 13 horas
ceuta, España Rephine A tiempo completoJoin Rephine Barcelona: Leading Life Sciences Quality Worldwide. At Rephine, we set the gold standard for quality assurance and GxP compliance in the Life Sciences industry. No espere a enviar su solicitud después de leer esta descripción; se espera un gran volumen de candidaturas para esta oportunidad. With offices in Barcelona, the UK, India, and China,...
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Quality Assurance
hace 15 horas
Ceuta, España Rephine A tiempo completoJoin Rephine Barcelona: Leading Life Sciences Quality Worldwide At Rephine, we set the gold standard for quality assurance and GxP compliance in the Life Sciences industry.No espere a enviar su solicitud después de leer esta descripción; se espera un gran volumen de candidaturas para esta oportunidad.With offices in Barcelona, the UK, India, and China, we...
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Ceuta, España G&L Scientific A tiempo completoPlease note this position can be located in our offices in Barcelona with 2 days on site. Asegúrese de leer detenidamente la información sobre esta oportunidad antes de presentar su candidatura.G&L Scientific is a specialist provider to the healthcare industry for all types of Regulatory Affairs and Quality Assurance consultancy work – and we are rapidly...
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hace 16 horas
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hace 15 horas
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Quality Lead
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hace 2 semanas
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Ceuta, España OPIS A tiempo completoOverviewDue to our ongoing global expansion, we have a great opportunity for a Regulatory Submissions Specialist to join our growing regulatory team in Taiwan, on a fully remote basis. Las cualificaciones, habilidades y toda la experiencia relevante necesaria para este puesto se pueden encontrar en la descripción completa a...
