Biological QA Specialist & Qualified Person (QP)
Pharmacist with QP experience in Biologics? Lead global launches and manage international CMOs. Apply now for this high-impact, technical Corporate Quality role!
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The role:
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.
Hybrid working environment based in Barcelona.
- Department
- Pharma & Medical Devices & Chemicals
- Role
- Quality
- Locations
- Barcelona
- Remote status
- Hybrid
- Employment type
- Full-time