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