Validation Specialist
Job Location :
Bandar Sunway Malaysia SelangorWe 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.
Your role
- 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.
Our offer
- 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)
Recruiter Responsible for offer
Nelson Dass
nelson.dass@billennium.com