PM Group requires a Systems Quality Assurance Engineer to be based onsite with our Bio-Pharmaceutical Client in Sligo.
Validation duties including the review / approval and acceptance of validation protocols of various systems including facilities, utilities, information technologies and equipment to ensure compliance with current regulatory expectations, EU, FDA and Corporate Standards and client specific procedures. Investigation / testing of deviations found
Taking part in the project change control program and deviations for modifications to new and existing equipment.
Act as the QAV lead in validation activities in project work-streams involving cross-functional, multidepartment teams including Operations, Quality Control, Quality Assurance, Engineering and others.
Resolve and assist in the closure of discrepancies initiated during Qualification execution.
Ensures that change requests and Document Change Requests are compliant with all applicable procedures. This will involve actively reviewing the change request documentation and the underlying documents for compliance.
Implement and revise as applicable Quality Validation procedures.
Conduct training in Validation Methodologies and related procedures as required.
Level 8 Degree in relevant science and/or engineering
Minimum of 5 years experience working in a regulated environment preferably within a Phrma/Biotech facilty
5 years Validation experience with strong knowledge of csv/gamp, 21 cfr part 11, project life cycle and cgmp regulations