Software Quality Assurance Manager

ICDS Recruitment

Waterford

SOFTWARE QUALITY ASSURANCE MANAGER - Waterford. DESCRIPTION. The Software Quality Assurance Manager will manage Software Quality Assurance activities and resources associated with the verification and validation of Shop Floor Information Systems and other computerised systems. The Software Quality Assurance Manager will manage Software Quality Assurance activities and resources associated with the verification and validation of Shop Floor Information Systems and other computerised systems in use in the manufacturing and release of Pharmaceutical Products and Medical Devices (Contact Lens). He/she will be responsible for facility compliance with regulatory commitments, in-house requirements and cGMPs in regards to computerized systems. SQA Activities: Responsible for facility compliance with regulatory commitments, in-house requirements and GMP in regards to computerized systems. Development of quality systems for Computer systems and support departments (IM&T, Engineering Development) by means of research and assessment of current industry practices and GMP requirements. Lead in Software Process Improvement activities. Preparation of procedures and policies for area of responsibility. Investigation of software related deviations as part of quality team. Prioritising SQA workload. Responsible for SQA review of all software related GMP critical documents, e.g. Requirement documents, software validation protocols, Change Controls. Manage the Software Non Conformance process Manage the software corrective action process, perform root cause investigations, develop CAPA plans and lead software related CAPA's. Manage software process improvement initiatives. Organize and deliver training in System procedures for required personnel. Lead and participate in risk management activities e.g. FMEA's. Participate in the site internal audit programme. Validation Activities. Provision of support and assistance in execution and control of Computerised System Validation programs. Manage validation policies. Review of pre-delivery or vendor supplied information in regards to suitability to proceed with validation activities. Development of protocols, test scripts and associated support documentation Perform the execution of software relatedprotocols. Responsible for managing the Corrective Action process in regards to individual validations to ensure follow-up and effective resolution. General: Carry out all activities in compliance with company Safety & Environmental and cGxP Standard Operating Procedures. Participate in team based project work and plant-wide initiatives to improve the GMP compliance and financial performance of the Waterford plant. Participate as member of Global SQA Team. Other duties as assigned by management. Key cGMP Responsibilities: Maintain, develop and manage SQA systems to cGMPs. 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. Requirements: 3rdlevel qualification in software or computer related discipline. Qualified lead auditor. Project management desirable. Ability to evaluate and assess information to determine appropriate risk and required actions is critical. Training skills are essential, with ability to lead and motivate a team. Ability to influence individuals and groups. Good communication skills - written and oral. Organizational skills are essential. Ability to identify improvement needs. Attention to detail is essential. At least 5 years' experience in a similar role in a GMP regulated environment. At least 4 years supervisory/management experience. Experience of scientific report writing including such documents as SOPs, protocols, deviations, reports, etc. This job originally appeared on RecruitIreland.com.

2494 days ago