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Freelance process validation / ppq consultant

Barcelona
Autónomo
Qualitice
Publicada el 23 diciembre
Descripción

P Freelance Process Validation / PPQ Consultant /p pstrong San Sebastián | On-site / Hybrid | Jan–Mar /strong /ppstrong For a pharma manufacturing project /strong in Spain, Qualitice is looking for an experienced strong freelance Process Validation / PPQ Consultant /strong to support strong initial commercial validation activities /strong. /pp This is a strong hands-on, execution-focused role /strong with on-site technical oversight responsibilities. /p p Scope of work /pp In this role, you will: /pp✅ strong Lead the Process Performance Qualification (PPQ) strategy /strong, including authoring, executing, and reporting PPQ protocols for strong initial commercial validation /strong /ppstrong✅ Develop and execute mixing studies /strong to establish and justify critical mixing parameters in support of PPQ acceptance criteria /pp✅ Provide strong on-site technical oversight of PPQ manufacturing runs /strong, ensuring: /pulli Adherence to approved protocols /lili Proper deviation identification and management /lili Data integrity and GMP compliance /li /ulp✅ Collaborate closely with Manufacturing, QA, Engineering, and Technical Operations /pp✅ Review and finalize PPQ documentation, reports, and associated records /p p Project setup /pullib Duration: /b approx. b2–3 months (January–March) /b /lilib Location: /b b San Sebastián, Spain /b /lilib Working model: /b Hybrid, with b on-site presence required (ideally every other week) /b /lilib Engagement type: /b b Freelance / independent consultant /b /li /ul p Required profile /pp Proven, hands-on experience b leading PPQ activities /b in GMP manufacturing /pp Strong background in b process validation and mixing studies /b /ppb Experience with initial commercial validation /b /ppb Comfortable providing on-site technical oversight /b during execution phases /pp Strong understanding of b GMP, deviation management, and data integrity /b /ppb Fluent Spanish – mandatory /b /ppb Fluent English (working language for documentation and stakeholders) /b /ppb Freelance setup required /b (autónomo, EU freelancer, or equivalent) /p p Why collaborate with Qualitice on this project? /pp Critical, execution-phase project with real impact /pp Clear scope and time-boxed assignment /pp✈️ Travel fully covered /p

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