CSV Consultant

CPL

Cork Or Limerick , Dublin West

Our client has an immediate requirement for an experienced CSV Consultant to join their team on a permaennt basis. The role canbe based in Dublin or in Cork to suit the successful candidate. Project Manager (CSV. SUMMARY. This role has 2 elements, both developing and enforcing the Quality Systems for projects and taking the Computer Systems Validation role for Life Science projects. This project experience gives the necessary understanding to deliver appropriate Quality Systems. Both roles require someone who is prepared to be the Quality ‘voice’, and who will champion quality on projects as well as within the department. RESPONSIBILITIES. Quality Systems. Work with UK/I management and PMO team to enhance the Quality Management System (QMS) which includes procedures, templates, tools and good practices. Perform internal audits on projects to ensure quality standards are being met. Feedback internal audit actions to the Quality Manager and PMO team. Work with operations manager to resolve individual project and company quality issues. Perform quality training to engineers and managers. Ability to establish a quality culture within the project teams. This means that each member knows what they need to do on a particular project, and how procedures expect them to do it. Work with project teams to develop, for a given solution, best practices for design and code review, implementation and testing. Establish templates which can be supplied to PMO. Validation Consultant. Review Project Quality Plan, and ensure good communication to project team, providing training where necessary. Provide guidance, training and updates on GAMP/GMP (current and future versions. Work as part of the sales team to establish relationship with customer’s validation team. Assess support that they require and services that may be sold to them. Work with customers to establish project validation strategy (VMP, VP) and ensure this is reflected in testing strategy (OTP, Test specifications. REQUIRED EXPERIENCE. Technical degree or equivalent with at least 10 years experience with focus on the life-science industry and a proven track record. Proven experience with IT Quality Management and Computerized Systems Validation (GMP, 21CFR Part 11, GAMP) together with PCS/MES application implementation and deployment in the regulated pharmaceutical industry including awareness of customers’ responsibilities. Good knowledge of European and International major pharmaceutical regulatory requirements (FDA, EMEA, ICH. Trained in ISO 9001 with auditor training and relevant experience. Ability to influence the culture of a project team or department to adopt and maintain good quality standards. Experience in Quality Management and Quality Systems development. Our client will offer the successful candidate a competitive salary along with a company car, bonus, healthcare and pension. If interested please contact Eoin Coffey on 061 221707 or email eoin.coffey@cpl.ie for more details. This job originally appeared on RecruitIreland.com.

2609 days ago