HSE Advisor

2. 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.

3. 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.

4. 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.

5. 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.

6. 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

7. 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

8. Qualifications & Experience

• Degree or Diploma in Environmental Health & Safety (or equivalent)

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