It Compliance Executive

JOB PURPOSE

• Ensure process and system GxP and Non GxP are complied with MITS, DI, and CS regulation. Promoting awareness of MITS and DI.

YOUR TASKS AND RESPONSIBILITIES

• Ensure compliance of local regulation related to CSV, MITS, and DI topic for GxP and Non GxP system.
• Support IT Compliance Associate Manager to perform evaluation of Global CMS (Compliance Management System) and manufacturing IT Security Implementation in the SMIT area
• Act as trainer and ambassador to raise awareness of MITS, CSV, and Data integrity
• Lead CAPA Management from CSV, MITS, data Integrity, As well as managing deliverable from Change Management, Deviation Management, Self-Inspection and Audit Management assigned as agreed timeline. 
• Support IT Compliance Associate manager to provide monthly KPI report and SQMR related specific topic area assigned.
• Provide adequate support for investigation and resolution of IT Security, CS and Data Integrity compliance issue in IT/OT System.
• Identify potential area of improvement within Regulation of MITS, CSV, and Data integrity.

WHO YOU ARE

Education

• Bachelor degree on Computer Science or relevance subject

Relevant experiences

• Min. 5 years experience in application or infrastructure support
• Min 2 years experience in software development lifecycle
• Have experience in lead project and project management
• Having knowledge in Manufacturing IT Security Principles, Computerized system and Data Integrity principles will be advantage
• Familiar with GxP regulated environment

Main competencies for the job (Core, Leaders, technical competencies)

• Good communication skill
• Able to work as individual and in team
• Good analytical thinking
• Have experience / knowledge in managing multiple stakeholders

Communication

• Fluent in English both verbal and written