Description
Our client is a global pharmaceutical company located in Walloon Brabant and is currently looking for an IT Compliance Consultant to bring Quality Assurance expertise to their IT QA department. The IT QA Consultant will be based in Walloon Brabant for at least 3 months.
Scope of work:
* Global QA expert member of the IT Quality & Compliance Center of Excellence
* Support computer quality & compliance and provide oversight of progress and issues
* Provide QA Oversight to the Automation team and to the IT organization.
* Be a member of the IT Quality & Compliance Center of Excellence.
* Drive adherence to computer quality & compliance programs at global level.
* Review and approval of global documentation for central IT systems and multi-site systems.
* Ensure QA requirements for IT systems and for automated and analytical systems are covered.
* Support harmonisation, improvement and alignment with QMS. Maintain an awareness of industry publications, guidance and emerging changes to regulations in order to pro-actively support compliance status.
* Establish links with contacts in related groups in order to share practices and knowledge across business units. Represent business on organization-wide initiative as required, including development/update of policies, sharing of inspection intelligence and Quality Alert.
* Be the global contact and facilitator to support sites' QMS implementation and partner with QMS team to ensure any specific regulatory requirements are incorporated into QMS.
* Share expertise and knowledge to provide input for sites and global functions performing their internal audits and inspection readiness where required.
* Support sites and global functions for corporate audits and regulatory inspections.
* Support, communicate and follow-up on key Quality issues related to Computer Compliance, including CAPA globalisation, change control, and support sites' inspection responses as required.
* Participate as subject matter expert on Compliance Management Team meetings where necessary to ensure adequate representation of Computer Compliance issues for discussion and escalation.
Requirements:
* Strong knowledge in IT quality assurance and computer compliance.
* Significant experience in Computer System Validation is mandatory.
* Expert knowledge of appropriate regulations including CFR, Eudralex, and industry publications such as GAMP, ICH, PIC/S.
* Good knowledge in Good Manufacturing Practices and Quality Management System (QMS).
* Ability to build and maintain a network of contacts across all sites and appropriate Global Functions, ensuring appropriate sharing of knowledge and expertise across teams.
* Ability to summarize, write and present technical subjects to Senior Management.
* Fluent English (written and spoken).
* Willingness to travel to sites when required.
Keywords: CSV, QA, computer system validation, quality assurance, GAMP, 21 cfr, IT compliance, eudralex, CSV