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2 weeks ago
We are seeking a skilled Quality Assurance Specialist to join our team in Singapore. The successful candidate will be responsible for promoting and integrating quality into every aspect of our biologics safety testing business.
The Quality Assurance Specialist will perform batch record review, including reviewing and approving GxP documents, conducting in-process or final audits, and releasing certificates of analysis. They will also assist in investigations from events, complaints, or data audits, and conduct trend analysis for deviations.
- Review and approval of GxP documents, including protocols, technical specifications, batch records, workbooks, SOPs, and other QMS documentation.
- Compliance with all applicable policies, procedures, and guidelines.
- Conducting in-process or final audits and approval on manufacturing or testing documentation.
- Release of the certificate of analysis for GMP testing against the TS and associated documentation.
- Preparing QA statements within each GLP final report.
- Review and approval of deviations, anomalous results, OOS, positive results, and CAPAs.
A graduate degree in life sciences or a higher related field is required. A minimum of 2-4 years of experience in a similar Quality Assurance role is preferred. Awareness of Biologics regulatory environment and GMP manufacturing topics is essential. A proactive approach to all aspects of Quality is necessary.
- Technical and problem-solving skills.
- Strong analytical and problem-solving abilities.
- Organized and logical in defining workload and delivering projects.
Our ideal candidate will possess strong communication and interpersonal skills, with the ability to work effectively in a team environment. If you are a motivated and detail-oriented individual with a passion for Quality, we encourage you to apply for this exciting opportunity.
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