Senior QA Professional

4 days ago

Singapore beBeeQualityAssurance Full time $60,000 - $80,000

We are seeking a Quality Assurance Specialist to support our team in ensuring excellence in quality assurance.

Our ideal candidate will have a graduate degree in life sciences and a minimum of 2-4 years of experience in a similar role, preferably in batch record review.

The successful candidate will be fluent in English, possess strong analytical and problem-solving skills, and be able to communicate effectively with operational teams and site QA and lab colleagues.

We offer a competitive salary and benefits package, opportunities for professional growth and development, and a collaborative work environment.

Additional requirements include a global mindset and the ability to engage in conference calls at out-of-office hours.

  • Key Responsibilities:
  • Batch record review: Review and approval of GxP documents, including protocols, technical specifications, batch records, workbooks, SOPs, and all other QMS documentation.
  • Batch record review: Comply with all applicable policies, procedures, and guidelines.
  • Batch record review: Conduct in-process or final audits and approval on manufacturing or testing documentation as they comply with stated regulatory standards and approved TS, protocol, or SOPs.
  • Batch record review: Release of the certificate of analysis for GMP testing against the TS and associated documentation.
  • Batch record review: Prepare QA statement within each GLP final report specifying inspection dates and dates findings were reported to the Study Director and management.
  • Review and approve deviations, anomalous results, OOS, positive results, and CAPAs.
  • Assist in investigations from events, complaints, or data audits.
  • Conduct trend analysis for deviations and review/approve applicable CAPA records.
  • Assist self-inspections to ensure continuous improvement.
  • Perform and support client audits, regulatory inspections.
  • Perform and support internal audits.
  • Perform and support supplier audits.

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