Lead departments in the review of current practices and SOP processes by collaborating with cross-functional teams to develop quality plans and set measurable quality objectives.
Create and update inspection and testing protocols.
Develop, implement, and maintain quality assurance policies and procedures.
Ensure that all processes and products comply with relevant standards and regulations.
Understanding and working knowledge of Good Distribution Practice for Medical Device in Singapore (GDPMDS)
Conduct regular internal audits to assess compliance with quality standards.
Prepare for and participate in external audits from regulatory bodies
Provide training to employees on quality standards, procedures, and best practices.
Ensure that staff is aware of and compliant with quality requirements.
Maintain accurate and up-to-date quality documentation, including records of inspections, tests, and audits.
Ensure that documentation meets regulatory and industry standards.
Identify and assess risks related to quality and work on mitigation plans.
Implement risk management strategies to avoid quality issues.
Requirements
Degree with a minimum of 3 years of relevant experience biotech/ medical industry
Familiar with regulatory assessments and accreditation preparation and audits
Change management experience a plus
Company information
Registration No.
201410806W
EA No.
14C7092
Employer questions
Your application will include the following questions:
How many years\' experience do you have as a Quality Assurance Manager?