Associate Specialist, Quality Systems & Compliance (WDA) -2 years contract
The position of Associate Specialist in Quality Management Systems (QMS) provides oversight on Quality Management System on site. The role will ensure and maintain high standards of quality and compliance within our organization.
In this role, you will be responsible for all or subset of the key responsibilities below:
- Manage overall QMS implementation in alignment with global.
- Develop Annual Schedule for QMS System health check and manage process/ platform to ensure adherence to schedule.
- Work with Site SMEs to prepare and ensure on time collation of site management review deck but not limited to site/quality metrics for reporting to site and corporate management.
- Act as Site Quality Risk Management (QRM) Champion and manages Site Quality Risk Management Committee (SQRMC).
- Manage and perform the annual mock recall challenge for the Singapore Site.
- Perform quality review and approval of QMS gap assessment.
- Proactively identify and drive improvements in consultation with manager & stakeholders.
- Act on escalations/feedback from stakeholders and work with cross functional teams to resolve the issues.
Qualifications & Experience
- Bachelor's degree in Science/ Life Science, Pharmaceutical Science, Engineering or proven relevant experience.
- Minimum 2-4 years of applied professional work experience in quality operations/quality management system.
- Good knowledge and understanding of GMP and application of pharmaceutical regulatory requirements
