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 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 records
Project setupDuration:
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 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 experience
Interested or available?Please share:Your
CV or consultant profile
Availability (Jan–Mar mandatory)Your day rate expectation
jobs@qualitice.com
or contact me directly via Linked In.