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Lab Validation Specialist
Eingestellt von Quanta Consultancy Services
Gesuchte Skills: Engineering, Support, Engineer
Projektbeschreibung
LAB VALIDATION SPECIALIST
DUBLIN AREA
Our client is looking for a Laboratory Validation specialist to support a small Biotech laboratory near Dublin for a 12 month contract initially. The validation engineer will require laboratory validation experience, CFR and PQ, as priority.
Role and Responsibilities:
. The purpose of the position is to provide Quality review of validation documentation to ensure compliance with cGMP, GAMP 5, Corporate Directives, FDA and EMA Regulations and ICH and PIC Guidelines.
. 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
. Quality Engineering or Quality Assurance Qualification an advantage.
. 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.
DUBLIN AREA
Our client is looking for a Laboratory Validation specialist to support a small Biotech laboratory near Dublin for a 12 month contract initially. The validation engineer will require laboratory validation experience, CFR and PQ, as priority.
Role and Responsibilities:
. The purpose of the position is to provide Quality review of validation documentation to ensure compliance with cGMP, GAMP 5, Corporate Directives, FDA and EMA Regulations and ICH and PIC Guidelines.
. 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
. Quality Engineering or Quality Assurance Qualification an advantage.
. 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.
Projektdetails
Geforderte Qualifikationen
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Kategorie:
Ingenieurwesen/Technik, Sonstiges