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Qp&qa manager

Barcelona
Actual Talent Spain
Publicada el Publicado hace 8 hr horas
Descripción

P Winid is a talent acquisition consultancy that offers Executive Search, RPO and Talent Solutions. /pp 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. /pp------------------------------------------------------------------------------- /pp About the client: /pp It´s a well-established global pharmaceutical development and licensing company that is expanding its operations into the European Union by setting up a dedicated testing and EU release site in Spain. With over 150 finished products licensed to more than 100 partners across EMEA, APAC, LATAM, and North America, the company is now investing in local infrastructure to offer direct support to its European B2B partners. /pp Job description: /pp This new facility will house a state-of-the-art quality control laboratory focused on oral solid dosage forms. As the Qualified Person Quality Assurance (QPQA) Manager, you’ll play a central role in building this project from the ground up—developing systems, interacting with authorities, and establishing a new team that will carry forward the company’s commitment to quality and compliance. /pp What You’ll Do: /pulli Define and implement the site’s Quality Policy in alignment with GMP and GDP guidelines. /lili Establish and maintain a robust, inspection-ready Quality Management System (QMS). /lili Review and approve key documentation: CoAs, SOPs, analytical methods, product specs, and work instructions. /lili Evaluate batch documentation for manufacturing and packaging to ensure EU GMP and MA compliance prior to release. /lili Investigate and manage deviations, OOS/OOT results, CAPAs, and Change Controls. /lili Oversee Quality Agreements with CMOs, subcontractors, and B2B clients. /lili Act as the company’s representative in regulatory inspections and client audits. /lili Lead the qualification and ongoing oversight of CMOs and third-party suppliers. /lili Serve as the primary point of contact for quality-related discussions with manufacturers, clients, and regulators. /lili Recruit, build, and lead your own Quality and QA team as the site grows and operational needs expand. /li /ulp Who You Are: /pulli Degree in Pharmacy and EU-recognized Qualified Person (QP) certification. /lili Experienced as a Qualified Person or Deputy QP, or a candidate with a Pharmacy degree and at least 5 years in Quality Assurance within the pharmaceutical industry. /lili Deep understanding of EU GMP requirements and quality systems. /lili Prior experience with oral solid dosage forms is highly desirable. /lili Fluent English speaker, with excellent written and verbal communication skills. /lili A hands-on, detail-focused leader with strong problem-solving capabilities. /lili Comfortable in a dynamic, entrepreneurial setting where you can make things happen. /li /ulp Why This Role Is Unique: /pulli Create something meaningful: Be part of designing and certifying a new EU lab and release site. /lili High-impact leadership: Set the quality vision and culture while recruiting and developing your own team. /lili Global collaboration: Interact directly with international manufacturers, clients, and regulators. /lili Strategic project: High visibility within a stable and globally active pharmaceutical company. /lili Professional growth: Competitive compensation, autonomy, and the opportunity to grow with the business. /li /ul

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