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 protocols- Proper deviation identification and management- Data integrity and GMP compliance✅ Collaborate closely with Manufacturing, QA, Engineering, and Technical Operations✅ Review and finalize PPQ documentation, reports, and associated recordsProject setup- Duration: approx. 2–3 months (January–March)- Location: San Sebastián, Spain- Working 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🤝 Professional, senior-level collaboration💶 Competitive freelance day rate, aligned with experienceInterested or available?Please share:- Your CV or consultant profile- Availability (Jan–Mar mandatory)- Your day rate expectation📧 jobs@qualitice.comor contact me directly via LinkedIn.