Description
QA Validation Engineer required for a 6 month contract with a global pharmaceutical company in Dublin.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.
Working within a new biologics laboratory the QA validation engineer will be responsible for qualification of instrumentation and software for a laboratory group.
Role and Responsibilities:
. Quality review and approval of Equipment Validation Protocols, including Validation Masterplans, Design documents, Process and Instrumentation Drawings, IQ, OQ, PQ protocols.
. 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.
. 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
This is an excellent opportunity with a global company with the expectation of work past the initial 6 month period.