Biologics Quality Assurance Professional
3 days ago
Job Title: Biologics Quality Assurance Specialist
Job Description:We are seeking a highly skilled Quality Assurance Specialist to join our organization 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.
Main Responsibilities:
- 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. Minimum 2-4 years of experience in a similar Quality Assurance role. Awareness of Biologics regulatory environment and GMP manufacturing topics. A proactive approach to all aspects of Quality.
Key Skills:
- Technical and problem-solving skills.
- Strong analytical and problem-solving abilities.
- Organized and logical in defining workload and delivering projects.
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