CQV Lead- BioPharma-Hybrid/Remote
Core
Lead the preparation and lifecycle management of CQV (Commissioning, Qualification, and Validation) documentation for pharmaceutical and nutritional sector projects.
Role type
Senior CQV Documentation Lead
Builds
Audit-ready validation documentation and compliance artifacts for Life Sciences clients
Domain
Life Sciences / Pharmaceutical Manufacturing / Regulatory Compliance
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
CQV lifecycle document development, validation protocol authoring, document version control, regulatory compliance knowledge (GMP, Annex 15, ASTM E2500), traceability matrix creation, risk assessment support, cross-functional coordination
Preferred skills
Experience with URS, DQ, IQ, OQ, and PQ protocols, familiarity with site-specific quality systems
Technologies
Microsoft Office Suite, Document Management Systems
Responsibilities
Develop and review CQV lifecycle documents including URS, DQ summaries, IQ, OQ, and PQ protocols and reports; Author validation protocols and reports in accordance with site procedures and regulatory expectations; Ensure proper document formatting, version control, and traceability throughout the document lifecycle; Coordinate with CQV engineers, QA, and project stakeholders to gather and verify technical inputs; Support document revisions, approvals, and close-out activities to meet project timelines; Ensure documentation aligns with GMP (EU/FDA), Annex 15, ASTM E2500, and site-specific quality systems; Maintain audit-ready documentation by ensuring completeness, accuracy, and compliance; Track documentation status and support timely delivery of validation deliverables; Assist in risk assessments, traceability matrices (RTM), and change control documentation; Collaborate with cross-functional teams including Engineering, QA, Automation, and external vendors
Seniority
Senior, hands-on IC