Risk Assessment & Permit-to-Work
Review, assess and approve CQV-specific risk assessments.
Ensure the effective implementation and governance of Permit-to-Work (PTW) systems, including:
Lock-out / Tag-out (LOTO) and complex system isolations
Confined space entry (e.g. tanks, vessels, HVAC plenums)
Hot works in both GMP and non-GMP environments
Support the safe de-isolation, recommissioning and re-qualification of systems during start-up activities.
Field Safety Oversight & Contractor Management
Conduct routine EHS inspections and safety walks in GMP and non-GMP areas throughout CQV execution.
Monitor and enforce contractor and vendor compliance with site EHS requirements.
Intervene promptly where unsafe acts or conditions present a risk to personnel safety, asset integrity or product quality.
Incident Management & Regulatory Readiness
Lead or support incident, accident and near-miss investigations arising from CQV activities.
Ensure investigation records, corrective actions and supporting documentation are inspection-ready.
Support regulatory inspections and internal audits across start-up, commissioning and validation phases.
Maintain traceable EHS records demonstrating effective control of high-risk CQV activities.
Training & Safety Culture
Verify that CQV teams, contractors and vendors complete all required training, including:
Site EHS induction
GMP awareness
Task-specific safety training (e.g. LOTO, chemical handling, cleanroom behaviours)
Deliver CQV-focused toolbox talks addressing pharmaceutical and start-up-specific hazards.
Actively promote and reinforce a strong safety and quality culture, particularly during high-risk start-up phases.
Interfaces & Stakeholders
CQV Engineers, Leads and Validation Teams
Site EHS and Operational EHS functions
Quality Assurance (QA)
Operations and Manufacturing Science & Technology (MS&T)
Construction Management
Contractors, OEMs and Vendors
Key Deliverables
CQV EHS risk assessments and approval records
Permit-to-Work oversight and compliance documentation
Field safety inspection reports and SIMOPS reviews
Incident investigation reports and corrective action tracking
EHS input into CQV readiness reviews, system handover and validation documentation
Qualifications & Experience
Degree or Diploma in Environmental Health & Safety (or equivalent).
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