Clinical Systems CSV & Quality Specialist

The work

We are looking for a CSV and quality specialist to validate clinical and manufacturing systems under GxP. Engagements are described by system class and risk — never by sponsor or site names in public copy.

You will

• Author and execute IQ/OQ/PQ protocols aligned to GAMP-style risk assessments
• Trace user requirements to test evidence and deviation handling
• Support internal and external audits with complete, attributable records
• Partner with engineering so configuration changes remain in a controlled state

You likely have

• 6+ years in computer system validation, QA, or quality systems for regulated life sciences
• Working knowledge of GxP, data integrity (ALCOA+), and change control
• Experience with at least one major clinical, LIMS, or MES-class system
• Precise technical writing