Biologics Regulatory Compliance Officer

3 days ago

Singapore beBeeBiologics Full time $90,000 - $120,000

Biologics Safety Specialist

We are seeking a Quality Assurance Professional 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.

  • Key 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.

Required Skills and Qualifications:

  • 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.
  • Fluent in both written and spoken English.

Benefits:

  • Opportunity to work with a dynamic team.
  • Professional growth and development.

Other Information:

Technical and problem-solving skills are essential for this role. A strong analytical and problem-solving ability, as well as organizational and logical thinking, are also required.

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