Biological QA Specialist & Deputy QP
hace 2 días
Sallent
Actual Talent is the talent acquisition consultancy that offers Executive Search, RPO and Talent Solutions. Para ser considerado para una entrevista, por favor, asegúrese de que su solicitud se ajusta plenamente a las especificaciones del puesto que se encuentran a continuación. 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 About the client: On behalf of a leading European pharmaceutical company, we are seeking a Deputy Qualified Person (QP) to join their Quality team in Barcelona. This is a technical, hands-on position focused on quality oversight, batch release activities and lifecycle management of biosimilar medicinal products. The role offers the opportunity to work with both internally manufactured products and externally manufactured products through international CMOs. This is not a people management position. Instead, it is ideal for a quality professional who enjoys working closely with GMP documentation, batch certification, quality systems and product quality activities. The role supports a growing biosimilars portfolio and upcoming product launches across Europe. Key Responsibilities Batch Release & Certification • Support and perform batch certification activities for biosimilar medicinal products., • Review manufacturing, analytical and quality documentation prior to batch release., • Ensure compliance with EU GMP requirements and internal quality standards. External Manufacturing Oversight • Act as a quality partner for external CMOs located in Europe, the US and other international markets., • Participate in supplier audits and quality reviews when required., • Support quality oversight activities related to outsourced manufacturing operations. Quality Systems • Manage and support investigations related to deviations, CAPAs, change controls and product quality issues., • Participate in risk assessments and implementation of corrective actions., • Review and approve quality documentation, including Quality Agreements and technical records. Product Lifecycle Support • Contribute to new biosimilar product launches and lifecycle management activities., • Collaborate with Regulatory Affairs, Supply Chain, Technical Operations and external partners., • Support product quality reviews and ongoing compliance activities. Candidate Profile Required • Degree in Pharmacy and eligibility to act as a Qualified Person (QP) in Spain., • Approximately 4–8 years of experience within Quality Assurance in the pharmaceutical industry., • Experience working with biosimilar products., • Experience with one or more of the following pharmaceutical forms:, • Injectable products, • Liquid dosage forms, • Solid dosage forms, • Solid understanding of GMP requirements and pharmaceutical quality systems., • Experience managing deviations, CAPAs, change controls and batch documentation., • Fluent English and Spanish. Preferred • Experience as a Qualified Person (QP) or Deputy QP., • Experience with injectable pharmaceutical products., • Exposure to external manufacturing organizations (CMOs) and supplier oversight., • Experience participating in audits and regulatory inspections. What is Offered • Opportunity to work with a rapidly growing biosimilars portfolio., • Exposure to international manufacturing partners and global quality operations., • Participation in upcoming biosimilar launches across Europe., • High level of visibility within a collaborative and experienced quality organization. xcskxlj, • Hybrid working environment based in Barcelona.
