The QA Specialist will be a member of the project team that is designing, building, commissioning, and ultimately achieving regulatory approval for ongoing commercial operations of a new state-of-the-art pharmaceutical packaging facility at Amgen’s Dun Laoghaire site.
This person will focus on the HVAC aspects of the project.
The position will report to the Director of Quality and will be located in Dun Laoghaire, Ireland.
• Collaborate with cross functional team to deliver project deliverables on time, on budget, and with Quality requirements being met
• Deliver all Quality aspects for Project as per ASTM E2500 directive / CQ Master Plan
• Review and approve project documentation (FAT’s, FAT Closure Memos, IV’s, Vendor SAT’s, Amgen SAT’s, Functional Test Documents, Test and Balance Reports, Air Leakage Reports) ensuring that Quality requirements are met
• Represent Quality in all Level 1 Walkdowns both at Installation Complete and Final Walk
• Integral part of QRAES (Quality Risk Assessments) Final Report, Commissioning Summary Report and IOQ Final Report approval
• Contribute to equipment and process risk assessments
• Contribute to weekly and Daily HVAC CQV meetings
• Is a champion for safe working practices and safety initiatives within their area.
Qualifications:
Job Description
The QA Specialist will be a member of the project team that is designing, building, commissioning, and ultimately achieving regulatory approval for ongoing commercial operations of a new state-of-the-art pharmaceutical packaging facility at Amgen’s Dun Laoghaire site.
This person will focus on the HVAC aspects of the project.
The position will report to the Director of Quality and will be located in Dun Laoghaire, Ireland.
• Collaborate with cross functional team to deliver project deliverables on time, on budget, and with Quality requirements being met
• Deliver all Quality aspects for Project as per ASTM E2500 directive / CQ Master Plan
• Review and approve project documentation (FAT’s, FAT Closure Memos, IV’s, Vendor SAT’s, Amgen SAT’s, Functional Test Documents, Test and Balance Reports, Air Leakage Reports) ensuring that Quality requirements are met
• Represent Quality in all Level 1 Walkdowns both at Installation Complete and Final Walk
• Integral part of QRAES (Quality Risk Assessments) Final Report, Commissioning Summary Report and IOQ Final Report approval
• Contribute to equipment and process risk assessments
• Contribute to weekly and Daily HVAC CQV meetings
• Is a champion for safe working practices and safety initiatives within their area.
Qualifications:
We need : English (Good)
Type: Permanent
Payment: package
Category: Pharmaceutical
