Job Summary
The Quality Assurance Compliance Specialist personnel will play a vital role in maintaining the Singapore regulatory dossiers and registering products in Asia and conducting internal audits and audits of suppliers & service providers. This position ensures that the regulatory dossiers reflect the manufacturing and analytical processes and the company's Quality Management System (QMS) complies with the latest regulatory requirements and industry guidelines. The incumbent will support continuous improvement initiatives and collaborate with cross-functional teams to build robust quality systems for a successful, compliant manufacturing operations.
Responsibilities
Regulatory Affairs
- Maintain the Singapore regulatory dossiers and their archivals.
- Support the maintenance of the Hong Kong regulatory dossiers.
- Maintain regulatory submission trackers.
- Maintain product labels and package inserts.
- Establish and maintain a regulatory intelligence process for the company. This includes the intake of new regulatory requirements and the implementation of the requirements at the site.
- Register or support the registration of the products in Asia such as Cambodia, Indonesia, Malaysia and Vietnam.
Regulatory Compliance
- (Re-)Qualify suppliers e.g. via questionnaire or audit. Create and maintain an Approved Supplier List.
- Establish and maintain Quality Agreements with suppliers and service providers.
- Conduct internal audits periodically.
- Host and participate in GMP-GDP inspections.
Qualification and Experience
- Bachelor Degree or equivalent in Science-related field
- Minimum 5-7 years experience as a Regulatory Affairs personnel in the pharmaceutical or medical device industry
- Has problem solving and organizational skills
- Has a sense of ownership and accountability
- Able to work well with colleagues within the department and with other departments
