JO-2410-542004
QA - Validation Specialist
Biotechnology
Sligo – Permanent
I am looking to speak with candidates with Validation experience in a GMP Quality environment for the newly created role of QA Validation Specialist.
The successful candidate will support 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.
Why you should consider this role?
Our client is an expanding biotech site and is going from strength to strength. They are going to go into full scale production soon but right now it would be a great opportunity to gain some exposure to pre production operations. They offer full training and ongoing development and support for your career. The senior leadership team are very inclusive and feedback from placed candidates working there is that the variety and type of work they are undertaking is very interesting.
Day to day duties ;
Ø 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.
Ø 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.
Ø Manage assigned areas of Quality Management System (QMS) to ensure the manufacture of product in accordance with GMP and regulatory requirements.
Ø 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.
Ø Generate, review, and approve SOP's/other documentation as applicable to your areas of responsibility.
Ø Perform timely review and approval of site procedures and documentation to ensure compliance with GMP and regulatory requirements.
Ø Ensure schedules for review and approval of GMP /validation documents are maintained to support technology transfers and new product introduction project timelines.
Ø Ensure application of Quality Risk Management principles including the application of risk assessment tools such as FMEA
Ø Act as the QA lead in QA activities in project work-streams involving cross-functional, multidepartment teams including Operations, Quality Control, Quality Assurance, Engineering, and others.
Ø Actively contribute to continuous improvement activities.
Reach out to [email protected] or call me on 01 614 678
