Freelance process validation

hace 2 semanas

Madrid, España Qualitice A tiempo completo

Freelance Process Validation / PPQ ConsultantSan Sebastián | On-site / Hybrid | Jan–MarFor a pharma manufacturing projectin Spain, Qualitice is looking for an experiencedfreelance Process Validation / PPQ Consultantto supportinitial commercial validation activities.This is ahands-on, execution-focused rolewith on-site technical oversight responsibilities. Scope of work In this role, you will: ✅Lead the Process Performance Qualification (PPQ) strategy, including authoring, executing, and reporting PPQ protocols forinitial commercial validation✅ Develop and execute mixing studiesto establish and justify critical mixing parameters in support of PPQ acceptance criteria✅ Provideon-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, SpainWorking model:Hybrid, withon-site presence required (ideally every other week) Engagement type:Freelance / independent consultantRequired profile Proven, hands-on experienceleading PPQ activitiesin GMP manufacturing Strong background inprocess validation and mixing studies Experience with initial commercial validation Comfortable providing on-site technical oversightduring execution phases Strong understanding ofGMP, 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: YourCV or consultant profileAvailability (Jan–Mar mandatory) Your day rate expectationjobs@qualitice.comor contact me directly via Linked In.

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