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. xqysrnh
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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