APJ Quality Compliance Specialist
1 week ago
The Quality System Regulatory Affairs Specialist role is a key position in the APJ region, responsible for ensuring compliance with quality management systems and regulatory requirements.
- This position plays a crucial role in maintaining the existing Quality Management System (QMS) according to standards and applicable regulatory requirements.
This specialist reports to the Manager RA/QA Commercial Operations & EHS and is part of Global Quality Systems located in Singapore. The role will be an on-site position.
Duties and ResponsibilitiesThe primary responsibilities of this role include:
- SUPPORTING THE APJ functional commercial teams to maintain compliance with QMS processes and interact with 3rd party auditors during site assessments.
- Providing overall leadership to functional levels and support all regulatory and quality assurance related issues at CO side.
- Making recommendations for continuous improvement of QMS processes and direct resources in support of KPIs and other metrics.
- Verifying effectiveness of QMS by internal audits.
Key duties also include:
- Managing the QMS platform for creation of quality documents and quality trainings.
- Responsible for product registration activities in the APJ region where required.
- Maintaining positive relationships with relevant government and regulatory authorities.
- Supporting the APJ regulatory team in their registration activities.
- Coordinating post-market surveillance activities such as adverse events/complaints, recalls/field corrective actions in cooperation with Business Units.
To succeed in this role, candidates should have:
- A minimum of 2-3 years proven QMS and/or RA experience in the regulated industry.
- International experience in problem solving, complaint handling, or equivalent.
- A BSc degree or equivalent in science, engineering, or related field.
Travel requirements are estimated at 25%.
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