Manager â Quality and Cross IT Applications
Posted on :
13-07-2025
Employer Active
1 Vacancy
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Job Description
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
Employment Type
Full-time
Key Skills
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