Responsibilities:
- Responsible for monitoring and ensuring the quality of all the operation aspects of the facility according to the established SOP, GMP, GDP and GLP practices and regulatory requirements
- Responsible to brief the new operators on the GMP and hygiene briefing
- Responsible to brief the relevant maintenance, quality control personnel on the GMP and hygiene briefing that require to entering the dispensing area and production area
- Investigation of Product Complaints
- Review of BMR
- Initiation & follow up of Change Control and Deviations
- Perform qualifications, the process and cleaning validation
- Any ad-hoc duties as assigned by the superior
Requirements:
- Bachelor’s Degree
- 3+ years’ experience
- Demonstrate experience and skills in conduct audit, supplier management and site inspection readiness
- Strong knowledge and understanding of Quality System functions, manufacturing / packaging processes, validation, engineering drawings and basic statistical processes
- Good technical writing skills and communication as well as presentation skills
- Working knowledge of Microsoft Office, Microsoft Project, Statistical Software
