Description
I am currently recruiting for a 12 month role in Cork, Ireland.Job Purpose:
The Validation Engineer is a member of the QA Validation team, playing a key role in the planning and execution of validation activities related to project. Provide support for the validation activities associated with equipment & processes ensuring that all compliance issues and requirements of Company Validation Policies and Procedures are addressed.
Organisational Interfaces:
All Disciplines within the Manufacturing Facility, Outside Suppliers and QA related Equipment Suppliers.
Main Duties & Responsibilities:
- Conduct validation activities in compliance with US and EU regulations, GBSC procedures and EHS requirements.
- Participate in the design of systems and equipment to ensure that they comply with GMP requirements.
- Develop validation documentation as required (e.g. specifications, plans, protocols, procedures).
- Review and approve documents prepared by the validation team, other departments and contractor organisations (e.g. commissioning test plans, impact assessments, change controls).
- Execute qualification protocols as required.
- Compile relevant documentation from contractors, suppliers, and other departments for inclusion in reports.
- Prepare reports of executed protocols for review by QA.
- Initiate and implement change control activities in accordance with site procedures.
- Track and resolve exceptions during qualification activities.
- Prioritize qualification activities in line with the project schedule.
- Co-ordinate qualification activities with engineering, construction and commissioning activities.
- Co-ordinate qualification activities with contractors and vendors as required.
- Co-ordinate qualification document review and approval.
- Collate and organize qualification files for turnover to QADC.
- Attend identified training, required to fulfil the role of Validation Engineer.
- Assist in the development of training material for qualification activities.
- Participate in cross-functional teams as required.
- Deputises for the QA Validation Manager when designated as appropriate.
- Domestic and international travel may be required.
Principle Accountabilities:
- Process Excellence - Continuous Process Improvement
- Process/Quality Input for validation processes and new product introduction
- Inspection of products & processes
- GMP
If you would like to hear more about this opportunity please apply now or call me on immediately.
Alternatively, if you know anyone who might be suitable, we do offer £200 vouchers for any successful referrals.
To find out more about Real please visit www.realstaffing.com
Real Staffing, a trading division of SThree Partnership LLP | Registered office | 1st Floor, 75 King William Street, London, EC4N 7BE, United Kingdom | Partnership Number | OC387148 England and Wales