Quality Assurance

hace 6 días


ceuta, España Actual Talent Spain A tiempo completo

Overview Actual Talent is the talent acquisition consultancy that offers Executive Search, RPO and Talent Solutions. We partner with a high‑growth Biotechnology company in a global scale‑up phase that is disrupting its therapeutic area with the global launch of an innovative biological drug. Our purpose is to drive the growth and fulfillment of individuals and organizations through talent acquisition and development solutions focused on people, diversity, inclusion, innovation, and cutting‑edge technology. Responsibilities Act as the Qualified Person (QP), taking legal responsibility for the certification and release of every manufactured batch (GMP/GDP). Lead the technical relationship with international CMOs, ensuring that external production consistently adheres to the company's quality standards. Supervise the entire product lifecycle: from manufacturing changes to resolving quality incidents, deviations, and out‑of‑specifications (OOS). Ensure regulatory compliance across the new markets where the drug is being deployed globally. Represent the company before Health Authorities (inspections, audits, and official communications). Qualifications Education : Bachelor’s Degree in Pharmacy (legal requirement for the QP role); a Master’s degree in the Pharmaceutical Industry is a plus. Experience : At least 3‑5 years in QA departments, with proven previous experience acting as a Qualified Person (QP). Expertise : Solid experience with biological products, biotechnological drugs, or sterile injectables (aseptic processing, Annex 1). Languages : Advanced level of English (essential for daily communication with international suppliers and stakeholders). Mindset : Thrives in dynamic environments, with strong decision‑making skills and a high orientation toward quality and detail. What This Project Offers Direct responsibility over a high‑complexity scientific product. A professional, agile, and internationally focused work environment. The chance to be a key player in the success of an expanding Biotech with a global footprint. #J-18808-Ljbffr


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    Ceuta, España Rephine A tiempo completo

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    hace 2 semanas


    Ceuta, España Rephine A tiempo completo

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