Job Location :Bandar Sunway Malaysia Selangor
We are a global technology company with 20 years of experience. We employ over 1800+ specialists in the field of modern business support solutions. We have 7 branches in Poland and offices in India (Pune), Germany (Frankfurt), Canada (Mississauga) and Malaysia (Selangor). We create innovative IT solutions using our expertise in outsourcing, software maintenance & development and Cloud computing. As well as supporting the idea of Paperless World which aims at reducing the amount of paper used by the organizations and optimizing business processes.
- Supporting/ leading IT projects to ensure compliance with pharmaceutical regulations (EU agencies, FDA and PMDA), company policies and standards.
- Managing all aspects of the SDLC approach for Computer System Validation/ Assurance projects.
- Determining validation approach, identifying deliverables needed or impacted by a project / enhancement / or change for GxP computerized systems.
- Coordinating and leading validation effort to ensure completion of validation activities according to company CSV Policy and SOPs.
- Authoring, executing, and reviewing system and project documentation.
- Working collaboratively with cross functions within the organization.
Your skills & experience
- Experienced in Document Management within IT projects/ processes.
- Familiar with System Development Life Cycle: Waterfall and Agile methodology.
- Experienced and/or exposure in either one of the following - System Development life cycle/ Quality Transaction Monitoring/ Internal Audit.
- Mandarin Speaking (Nice to Have)
- Fluent in both written and spoken English.
- Basic understanding of Risk Management and compliance with process adherence in complex project environments.
- Able to work in cross-functional, multi-cultural team environments, as well as independently, and to manage multiple and completing projects are required.
- Additional Annual Leave (upon completion every 1 year in Billennium)
- Optical coverage reimbursement
- Flexible schedule
- Health insurance (including spouse and children)
- Maternity leave
- Paternity leave
- Transport allowance
- Integration activity (quarterly basis)
- Opportunities for promotion (reviewed every year)
- Professional development
- Work from home (hybrid mode)
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