- Planning and execution of QA strategies and procedures to assure compliance with all applicable regulatory requirements, quality system and current good manufacturing practice (cGMP) requirements.
- Daily management and coordination of the quality function to meet ongoing customer requirements.
- Developing and maintaining the quality system & documentation to ensure compliance with quality requirements
- Resolving all quality matters and monitor the quality system to comply with relevant standard and regulatory requirements.
- Is appointed as Management Representative for ensuring all requirements outlined in this quality manual are effectively implemented and maintained.
- Responsible to deal with any government regulatory agencies, industries associations, research institute or laboratory and standardization bodies on quality matters.
- To lead and motivate QA/QC team and lead validation team on shelf life study of finished products and validation on new products/machine/software.
- Possess Bachelor’s Degree holder in any Science field.
- Minimum 5 years experiences or equal position in quality management in manufacturing of medical/ pharmaceutical.
- Good knowledge on quality tools (7QC basic tools, SPC, 6 sigma, 8D report, FMEA).
- Knowledge in ISO 9001. ISO 13485, ISO 14971, FDA, validation process and audit experience is a must.
- Strong analytical, problem solving and decision making.
- Able to work independently and lead a team.