Description
Laboratory Validation specialist supporting a small Biotech laboratory near Dublin for a 6 month contract.
The validation engineer will be responsible for the completion of 21 CFR 11 assessments on lab equipment, creation/execution of IQ/OQ documentation, creation of SOP's.
Role and Responsibilities:
* The role would require completion of 21 CFR 11 assessments on lab equipment, creation/execution of IQ/OQ documentation, creation of SOP's.
* Projects will include supporting the qualification of plant computer systems such as Delta V, new plant equipment and also up-grades to existing computer systems and equipment
* Quality review and approval of Equipment Validation Protocols including Validation Masterplans, Design documents, Process and Instrumentation Drawings, IQ, OQ, PQ protocols.
* Participate in GMP Risk Assessments and FMEA's, compliance review of Risk Assessment documentation.
* Ensure equipment changes are implemented as per change control procedures.
* Project co-ordination & communication of validation issues to team members & management.
* Maintaining an up-to-date knowledge of EMA and FDA regulatory requirements.
Requirements :
* Degree in Engineering/Science Discipline
* Experience in computer system validation essential.
* Good working knowledge of Regulations and Guidelines, GAMP 5 requirements and ISPE Guidelines.
* Experience in the Pharmaceutical industry.
* Ability to participate in cross functional teams
If this is you please apply today.