Reports to: Key Account Manager
ISS Division: Integrated Solutions
Location: Dunboyne, Co. Meath
ISS in Ireland provides high quality facilities services designed to maintain the operation, fabric and appearance of all its client buildings. ISS provides Total Facilities Management; cleaning & hygiene services; maintenance and building services; landscaping and a wide range of other tailor-made services for customers throughout the Public and Private Sectors. The position will be situated at a client site in Co. Meath.
Reporting to the Key Account Manager and Global QEHS, the objective of this position is to develop and promote a best in class Quality, Environmental, Health and Safety programs, policies, procedures and culture on site, demonstrating leadership and commitment. Implement Stringent QMS incorporating as aspects GMP training, change control, audits, deviations and GMP vendor management etc.
- Minimum 5 years experience in Quality and or EHS relevant function within Pharma industry
- Implement annual global quality plan in customer activities as relevant.
- Report agreed performance measures to ISS group QA.
- Establish QA manual and SOPs.
- Implement changes from the global PQMS
- Responsible for ISS deviations.
- Managing of Investigations and CAPA’s.
- Manage Change Controls.
- Responsible for GMP training, develop material and associated documentation,
- Develop audit plan, perform audit of 3rd parties and follow up on performed audits.
- Contact group QA about observations that are suspected to be classified as critical.
- Prepare and host customer audits of national pharma segment operations and national PQMS.
- Establish CAPA plan and follow up on audits of National operations.
- Support the site with audit preparations, presence at audit and follow up on audit results
- Review audit reports and CAPA plans from the sites ensuring adequate follow up and reporting
- Prepare and host authority inspections of national pharma segment operations and the national PQMS.
- Support sites receiving authority inspections.
- Approve SI plans from the site.
- Keep both ISS and client representatives informed of critical and major observations.
- Establish and maintain QA agreements with subcontractors, involving customer approval.
- Managing overall QEHS Qualification of new and transferred subcontractors.
- Management of overall risk assessment process with CAPA Regularly review QA agreement in accordance with the actual services self-delivered and/or subcontracted.
Environment, Health & Safety:
- Lead and drive legislative and statutory compliance, providing advice and guidance to the ISS site team regarding new legislation/regulations/ industry best practice and other requirements.
- Manage the day to day running of the site specific HSEQ Management Systems providing support to the site team and ensuring compliance with ISO 14001 and 45001 standards
- As the HSE Subject Matter Expert provide advice on HSE ‘best practice’ to site management and front-line employees.
- Review and update site specific HSE documentation to ensure compliance with legislation and industry best practice.
- Promote, lead and manage H&S Management System portal, developing, reviewing and signing off risk assessments and method statements.
- Ensure adequate monitoring of all significant safety risks throughout the site including, ergonomics, hazardous environments, chemicals, fumes vapours, noise, mechanical, electrical, biological, and radiological exposures and develop site risk register.
- Lead accident, incident investigations, completing in depth root cause analysis, corrective actions and lessons learned.
- Responsible for Safe Systems of Work, permitting of high risk activities, LOTO, Working at Heights, Hot Works etc.
- Authorised person for EHS Lock Out Tag Out Equipment and supply of appropriate Personal Protective Equipment.
- Complete HSE audits and site inspections, identify non-conformance and track to closure.
- Monitor and measure HSE performance on site, tracking goals & action plans, analysis data, publish monthly reports, trend analysis and statistics.
- Manage chemical management system, chemical approval, safety data sheets and chemical risk assessments.
- Management of Life Safety Systems, develop SOP’s for critical systems, Emergency Shower Management, Legionella Program, Fire Safety etc.