Software Quality Assurance Engineer - Wa

ICDS Recruitment

Waterford

Software Quality Assurance Engineer with 3+ years experience required to validate and verify Shop Floor Information Systems and other computerised systems used in the manufacturing and release of products. You will be responsible for facility compliance with regulatory commitments, in-house requirements and cGMPs in regards to computerised systems. Requirements: At least 3 years' experience in a GMP regulated environment . A Degree in a science, engineering or computing discipline. Experience of scientific report writing including such documents as SOPs, protocols, deviations, reports etc. Ability to evaluate and assess information to determine appropriate risk and required actions is critical. SQL or other querying language experience. Training skills are essential, with ability to lead and motivate a team. Good communication skills – written and oral. Organizational skills are essential. Attention to detail is essential. Participate in team based project work and plant-wide initiatives to improve the GMP compliance and financial performance of the plant. Have the ability to communicate IT/Validation concepts/strategies to project teams. Be a self-starter. Be adaptable to a fast pace working environment. Be able to integrate and interact well with people. Responsibilities: Responsible for facility compliance with regulatory commitments, in-house requirements and GMP in regards to computerised systems. Preparation and execution of computer software validation protocols, test scripts and reports. Evaluation of changes to validated/qualified Systems from a Computer Systems/Software Validation perspective to ensure their continued validated/qualified state. Perform New Product Setup activities in line with procedures. Lead and participate in risk management activities e.g. FMEA's. Lead and participate in software related process improvement projects. Investigation of software related deviations and non-conformances as part of quality team and in line with company procedures. Review of all software related GMP critical documents, e.g. Requirement documents, software validation protocols, Change Controls. Review of pre-delivery or vendor supplied information in regards to suitability to proceed with validation activities. Compliance with company KPIs. Participate in the site internal audit programme. Deliver computer system training to users where required. Participate in software corrective action process e.g. perform root cause investigations and develop CAPA plans. Liaise with operations to ensure minimum disruption to the manufacturing process when implementing software changes. Carry out all activities in compliance with company Safety & Environmental and cGxP Standard Operating Procedures. Follow Standard Operating Procedures while carrying out duties at all times. Participate fully in all GMP and operational training programs and complete all Training Records in an accurate and timely manner. Please contact Emer Moore to discuss in confidence. 0035316321200. Emer.Moore@icds.ie. This job originally appeared on RecruitIreland.com.

2761 days ago