- Basic up to $5,000 + AWS + VB
- US MNC career opportunity
- Permanent opportunity
- Support the global/regional China DMF-related activities from pre-registration until post-registration.
- Writing technical reports as required to support China DMF submissions.
- Writing / updating existing QA documents related to China DMF project.
- Support necessary initiatives to continuously improve on the workflow and systems.
- Being a Subject matter expertise on quality systems and requirements.
- Provide input to and ensure consistency of the Technology Transfer documents from project initiation until completion of transfers.
- Analyze contents of the Tech Transfer documents, ensure critical quality attributes (CQAs) are challenged to prove product equivalency and mitigate identified risk.
- Work with Tech Transfer team to prepare Risk Assessment and Risk Mitigation documents for approval.
- Support customer notification and summary reports related to Technology Transfer.
- Implement and maintain the effectiveness of quality systems for the AP region.
- Set up a quality audit system to assess conformance to specifications, company procedures and customer requirements for the Asia Pacific plants.
- Other duties as assigned by manager.
- min. Diploma / Degree in any relevant Science discipline.
- Experinece in oharmaceutical / medical devices environment
- Knowledge in ISO 9001 / ISO 15378
(Note: Any resumes of job applications sent to this mailbox will not be attended as it is solely for the purpose of personal data protection related matters.)
Ng Kee Hung | R2091423
ScienTec Consulting Pte Ltd | 11C5781