Freelance Process Validation / PPQ Consultant
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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
Professional, senior-level collaboration
Competitive freelance day rate, aligned with experience
Interested or available? xqysrnh
Please share:
Your
CV or consultant profile
Availability (Jan–Mar mandatory)
Your day rate expectation
or contact me directly via LinkedIn.