Description
One of the top 10 best companies to work in Ireland is looking for more engineers for their new large-scale facility north of Dublin. Is this you?A QA Validation Engineer required to join a Global biotech company located in Dublin for an initial 9-month contract.
An exciting project there is lots of opportunities to learn new technology and develop current skills within a fast paced €1 billion project. This fantastic client offers the opportunity to work within a large-scale environment with cutting edge technology.
The QA Validation Engineer will be responsible for providing quality support for the qualification of the MES electronic batch record system at the new facility.
The experienced Quality Professional is required to ensure MES Computer System Validation documentation is in compliance with cGMP, GAMP 5, Corporate Directives, FDA and EMA Regulations, ICH and PIC Guidelines.
Role and Responsibilities:
- Provide GMP and Compliance oversight for the implementation and Validation of the electronic batch record system (MES).
- Provision of Real Time Quality Support during the execution of MES qualification/validation activities from IQ through to PQ including Defect and Change Management.
- Quality review and approval of Validation Documentation including Design documents, Functional Requirements, IQ/IOQ/PQ protocols and reports and Validation Masterplans.
- Provision of QA support for System and Recipe testing.
- Ensure MES system changes are implemented promptly and compliantly as per change control procedures.
- Degree in Engineering/Science Discipline.
- Proven background in the Quality review and approval of qualification/validation documentation within a pharmaceutical/biopharmaceutical manufacturing organisation.
- Experience in MES and Computer System Validation highly desirable.
- Ability to work weekends and shift (if required).