Freelance Process Validation / PPQ ConsultantSan Sebastián | On-site / Hybrid | Jan–MarFor a pharma manufacturing project in Spain, Qualitice is looking for an experienced freelance Process Validation / PPQ Consultant to support initial commercial validation activities.This is a hands-on, execution-focused role with on-site technical oversight responsibilities.Scope of workIn this role, you will:✅ Lead the Process Performance Qualification (PPQ) strategy, including authoring, executing, and reporting PPQ protocols for initial commercial validation✅ Develop and execute mixing studies to establish and justify critical mixing parameters in support of PPQ acceptance criteria✅ Provide on-site technical oversight of PPQ manufacturing runs, ensuring:Adherence to approved protocolsProper deviation identification and managementData integrity and GMP compliance✅ Collaborate closely with Manufacturing, QA, Engineering, and Technical Operations✅ Review and finalize PPQ documentation, reports, and associated recordsProject setupDuration: approx. 2–3 months (January–March)Location: San Sebastián, SpainWorking model: Hybrid, with on-site presence required (ideally every other week)Engagement type: Freelance / independent consultantRequired profile Proven, hands-on experience leading PPQ activities in GMP manufacturing Strong background in process validation and mixing studies Experience with initial commercial validation Comfortable providing on-site technical oversight during execution phases Strong understanding of GMP, deviation management, and data integrity Fluent Spanish – mandatory Fluent English (working language for documentation and stakeholders) Freelance setup required (autónomo, EU freelancer, or equivalent)Why collaborate with Qualitice on this project? Critical, execution-phase project with real impact Clear scope and time-boxed assignment✈️ Travel fully covered