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Freelance Process Validation
hace 2 semanas
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 profileProven, hands-on experience leading PPQ activities in GMP manufacturingStrong background in process validation and mixing studiesExperience with initial commercial validationComfortable providing on-site technical oversight during execution phasesStrong understanding of GMP, deviation management, and data integrityFluent Spanish – mandatoryFluent 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 impactClear scope and time-boxed assignment✈️ Travel fully coveredProfessional, senior-level collaborationCompetitive freelance day rate , aligned with experienceInterested or available?Please share:Your CV or consultant profileAvailability (Jan–Mar mandatory)Your day rate expectationor contact me directly via LinkedIn.
