QA Validation Lead (CSV) – GMP Sign-Off (Contract)

Panda International; Geleen; On-site; EUR 65,000 - 90,000; Full time

Job summary

Panda International is seeking a QA Validation Specialist (CSV) for a 6‑month contract onsite in Geleen, Netherlands.

In this documentation-led role you will review IQ/OQ/PQ records, provide QA final sign‑off that equipment is qualified, and coordinate with CSV, QC and engineering during ramp-up.

Requirements include GMP QA experience, ISPE guidelines, 21 CFR CSV knowledge, and strong attention to detail in a paper‑based review environment.

Qualifications

• Must have QA experience in GMP-regulated manufacturing.
• Knowledge of ISPE guidelines and 21 CFR (CSV).
• Experience qualifying non-computerized systems such as TCUs, fridges, freezers, and incubators.
• Ability to work independently in a desk‑based, paper/document review role.

Responsibilities

• Review IQ, OQ, and PQ documentation.
• Provide QA final approval/sign-off confirming equipment is qualified.
• Review validation protocols (review only).
• Support qualification of new equipment, including bioreactors, room expansions, and biosafety cabinets (BSCs).
• Qualify temperature-controlled units (TCUs) such as fridges, freezers, and incubators.
• Engage with deviations and change requests related to CSV/qualification activities.
• Coordinate with engineering, CSV, QC, and facilities teams to resolve issues.

Skills

QA experience

GMP knowledge

ISPE guidelines

21 CFR CSV

Communication

Tools

TrackWise

Kneat

Job description

Panda International is seeking a QA Validation Specialist (CSV) for a 6‑month contract onsite in Geleen, Netherlands.

In this documentation-led role you will review IQ/OQ/PQ records, provide QA final sign‑off that equipment is qualified, and coordinate with CSV, QC and engineering during ramp-up.

Requirements include GMP QA experience, ISPE guidelines, 21 CFR CSV knowledge, and strong attention to detail in a paper‑based review environment.