Description
A QA CSV Engineer is required for a 6 month initial contract in Dublin.The QA CSV Engineer will be responsible for providing quality support for the qualification of Computerised Systems at the new biologics facility.
An experienced Quality Professional is required to ensure Computer System Validation documentation is in compliance with cGMP, GAMP 5, Corporate Directives, Local procedures, FDA and EMA Regulations, ICH and PIC Guidelines.
Role and Responsibilities:
- Participation in Facilitated Reviews with multi-disciplined teams.
- Provision of Real Time Quality Support during the execution of qualification/validation activities from SAT to PQ including making decisions on quality issues.
- Quality review and approval of Computer System qualification Documentation such as FAT/SAT/IQ/OQ/PQ protocols and Validation Summary Reports.
- Ensure Automation/AIT changes are implemented promptly and compliantly as per Automation Change Control procedures.
- Providing compliance oversite for life cycle documentation, ie URS, DS, FS, SDS, HDS etc.
- Performing Leveraging Assessments.
- Review and approval of Quality Risk Assessments (QRA)
- Project co-ordination & communication of issues to team members & management.
- Degree in Engineering/Science Discipline.
- Experience with Delta V Process Automation System, Data Historians, Building Automation Systems, Asset Management applications, OEM PLC systems, Document Control applications and Trackwise desirable.
- Proven background in the Quality review and approval of qualification/validation documentation within a pharmaceutical/biopharmaceutical manufacturing organisation.
- Knowledge of ASTM E2500 risk approach to verification desirable.
- Good working knowledge of EMA/FDA Regulations and Guidelines (Annex 11, 21CFRPart11), GAMP 5 requirements and ISPE Guidelines.
- Ability to participate in cross functional teams in addition to working on own initiative.
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