Manager â Quality and Cross IT Applications

VAM Systems is currently looking for Manager Quality and Cross IT Applications for our UAE operations with the following skill set and terms and conditions: Qualifications: Desirable: Bachelors Degree with 10 years of IT Quality computerized systems compliance and SDLC experience in life sciences/manufacturing is required. Any key quality (GxP) certifications. Main Responsibilities: Ensure computerized systems are appropriately documented and validated. Subject matter expert on SDLC/Qualification procedure and able to provide CSV guidance to IT or Business. Ensure alignment and compliance of the IT quality and compliance with the organizational strategy goals and values as well as the applicable IT standards such as ISO CMMI ITIL etc. Leads the team for handling both Quality Financial Auditors (Internal/External) related to IT GMP and Non-GMP validation with the right kind of approach and strategy. Coordinating with cross-discipline team members to make sure that all parties are on track with project requirements deadlines and schedules. Plan and conduct internal and external audits and assessments of the IT processes products and services and report the results and recommendations to the management and relevant parties. Manage and coordinate the corrective and preventive actions and ensure their effectiveness and closure. Setting up Steering Project committee and communication with the steering committee members and project sponsor. Facilitate communication with the global team and help conflict resolution if conflicts arise escalate issues and seek resolution. Facilitate sign offs and Completion of Trainings within the stipulated project timelines. Help project teams define appropriate CSV strategies including stage gate deliverables. Prepare or review all levels of validation documents (internal or external) including: Reviews writes revises and maintain all IT related policies/ SOPs (GMP/Non-GMP). Provide training coaching and consultation to the IT staff and stakeholders on the IT Computerized System Policies SOPs best practices and improvement opportunities. Compile and analyze validation data and make recommendations for changes and/or improvements. Work with the business system owners and teams to support internal & external audits across to confirm compliance of the system with local and regional standards. Performs periodic reviews or re-qualifications to maintain current validation status of softwares and systems as defined by approved validation SOPs. Manage track and monitor all the IT CAPAs Deviation and change controls. Manage all ManufacturingGMP Solutions its contracts and documents. Conducting Gap Analysis and developing Remediation Plans. Excellent knowledge and good working experience on preparing the Corrective Action Prevention Action (CAPA). Managed routine IT change Control and configuration process. Routine IT Incident and deviation management. To manage the close cooperation with user department and suppliers for getting their extensive supports. Requirements (Knowledge Skills & Attributes) Essential: Understanding of GxP and Computer Systems / Automation role in support of GxP compliance is required. Proven knowledge and experience in applying and implementing various IT standards such as ISO CMMI ITIL etc and relevant pharma regulations such as CFR Part 11. Experience in SAP ECC S4HANA GxP GMP Reporting tools and EQMS solutions. Experience with Technical Document writing (SOPs) and development. Understanding of GAMP5 and risk-based approach to validation is required. Experience in the review of Validation Deliverables (Project Documentation). Ability to identify define and propose the quality framework improvements based on daily challenges is desired. Excellent communication presentation and interpersonal skills. Experience of working with Pharma/ Biotechnology. Ability to manage and/or coordinate projects from start to completion in Quality Compliance field. Participate on cross functional teams to validate/verify implement and maintain regulated (Example: GxP JSOX etc.) and/or non-regulated systems. Proven experience with IT Risk Management and Control policies and procedures. Proficiency in MS Office tools. Knowledge in Documentation Life Cycle and Good Documentation Practices. Experience in SOX controls - IT General Controls (ITGC) or General Computer Controls (GCC). Joining time frame: (15 - 30 days) Remote Work : No Employment Type : Full-time Key Skills Computer Hardware,IT Experience,IT Management,Network Installation,Vendor Management,Computer Networking,Microsoft Windows Server,Windows,IT Service Management,ITIL,SAN,Network Architecture Experience: years Vacancy: 1