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Senior Talent Partner at CPL - Science & Engineering : 01 614 6178
JO-2506-552925
QA Validation Specialist required for expanding biotech site in Sligo town. The successful candidate will have prior Validation experience in equipment, facilities and utilities in a GMP environment.
Get in touch with me for further information : Deirdre Murphy on 01 614 6178 / 087 180 4358 or [email protected]
* Site QA point of contact providing technical expertise, feedback and guidance for QA and compliance topics /issues including validation strategy /approach, new product introduction and manufacturing and assist in the resolution of issues commensurate with the level of risk.
* Review and approval of validation documentation and activities related to the qualification of the facility, equipment, and utilities to support start-up and on-going manufacturing.
* Manage assigned areas of Quality Management System (QMS) to ensure the manufacture of product in accordance with GMP and regulatory requirements.
* QMS areas of responsibility include Deviation investigations, Change Control and CAPA management systems; Internal/External audits; Vendor Management; review /approval Manufacturing Batch Records and assessment /approval of production materials.
* Generate, review, and approve SOP's/other documentation as applicable to your areas of responsibility.
* Perform timely review and approval of site procedures and documentation to ensure compliance with GMP and regulatory requirements.
* Ensure schedules for review and approval of GMP /validation documents are maintained to support technology transfers and new product introduction project timelines.
* Ensure application of Quality Risk Management principles including the application of risk assessment tools such as FMEA
* Act as the QA lead in QA activities in project work-streams involving cross-functional, multi-department teams including Operations, Quality Control, Quality Assurance, Engineering, and others.
* Actively contribute to continuous improvement activities.
Seniority level
* Seniority level
Entry level
Employment type
* Employment type
Full-time
Job function
* Job function
Quality Assurance
* Industries
Staffing and Recruiting
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