Freelance Process Validation
hace 5 días
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)
Travel: Flights and hotel covered
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?
Please share:
Your CV or consultant profile
Availability (Jan–Mar mandatory)
Your day rate expectation
or contact me directly via LinkedIn.
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