Freelance Process Validation / PPQ Consultant

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 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 jobs@qualitice.com

or contact me directly via LinkedIn.