Quality Engineer
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| Job Type | Contractor |
| Area | Dublin, Ireland |
| Sector | Quality |
| Start Date | |
| Advertiser | Ashling Guthrie |
| Job Ref | #2831 |
| Job Views | 1011 |
- Description
- Team Horizon is seeking a Quality Engineer for our client’s drug substance manufacturing facility in Dublin. In this role you will be responsible for will be responsible, with management support, for providing oversight of quality activities associated with Engineering, Automation and Validation activities.
Why you should apply:
This is an exciting role, where you will be responsible, with management support, for providing oversight of quality activities associated with Engineering, Automation and Validation activities.
What you will be doing:
Quality Oversight on new product introduction in Bulk Drug Substance facility.
Provide QA support for risk-based verification activities in the capacity of Quality Assurance Subject MatterExpert.
Review and approval equipment/utilities verification documentation from design to post execution.
Review and Approve project documents involving cross-functional, multi-departmental teams including:Operations, Process Engineering, Quality Control, Quality Assurance, Facilities, and others.
Participate in verification quality risk assessments and provide quality oversight to ensure verification quality risk assessments are effectively maintained/controlled.
Review and approval of validation documents for equipment, software and equipment qualifications, andothers. (e.g. URS, Facility, Utility, IT Systems, Test Method, and Equipment validations) to ensure
compliance with current regulatory expectations, EU, FDA and Corporate Standards and Internal
Procedures.
Investigation and approval of deviations generated encountered during qualification/validation testing and Participation in the project change control program and deviations for modifications to new and existing equipment.
Provide quality oversight of on-site engineering controls including calibration and preventative maintenance
programs.
Performs timely review of documentation/investigations/reports highlighting and assisting in the resolution of
issues commensurate with the level of risk
Ensures schedules for review and approval of GMP documents are maintained to meet the needs of
Commercial Operations groups.
Provide sound QA and Compliance support to manufacturing, engineering, utilities, supply chain and
material movement.
Provide support for deviation investigations, including root cause analysis, and corrective & preventative
action (CAPAs) proposals and initiatives.
Actively support audit readiness activities and regulatory agency and internal audits.
Represents Quality Assurance to guide various projects and technical meetings, as needed.
Responsible for documenting and reporting compliance issues to management.
Any other duties as assigned
What you need to apply:
A minimum of 5 years relevant experience within the pharma industry or a related field and 3 years of experience in QA technical role. Sound awareness and understanding of pharmaceutical business, especially with regards to quality and regulatory requirements.
Strong knowledge of cGMP requirements for pharmaceutical manufacturing and/or packaging required.
Experience of sterility assurance for drug products and in manufacturing processes for pharmaceutical products and processes strongly desirable.
Excellent accuracy and attention to detail
Good knowledge of relevant computer packages e.g. TrackWise or similar
Planning and organizing skills are required to plan, execute, and track commitments of Quality Assurance and to adjust to changing priorities.
