Freelance Process Validation / PPQ Consultant
San Sebastián | On-site / Hybrid | Jan–Mar
For 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 work
In 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 records
Project 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 consultant
Required 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