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Ensuring Excellence in Quality Assurance

2 weeks ago

Singapore beBeeQuality Full time
Job Title: Quality Assurance Specialist
Job Description:
Our company seeks a motivated Quality Assurance Specialist to join our team in Singapore. As a key member of the QA team, you will be responsible for promoting and integrating quality into every aspect of our BioReliance biologics safety testing business.
As a Quality Assurance Specialist, you will perform batch record review, ensuring that laboratory testing operates in full compliance with sound scientific practice, GxP, and Standard Operating Procedures (SOPs). You will also contribute to the results of the QA team and be accountable for the quality of your own work. You will analyze information, identify solutions, and take initiative to solve problems of low complexity independently.
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.
Required Skills and Qualifications:
Education:
Graduate degree in life sciences or higher related degree is required.
Experience:
Minimum of 2-4 years of experience in a similar Quality Assurance role, preferably in batch record review.
Skills and Abilities:

• Fluent in both written and spoken English.

• Strong analytical and problem-solving abilities.

• Organized and logical in defining workload and delivering projects.

• Good communicator, dealing directly and effectively with operational teams and site QA and lab colleagues routinely.

• Proactive approach to all aspects of Quality.
Benefits:
Our company offers a competitive salary and benefits package, opportunities for professional growth and development, and a collaborative work environment.
Additional Requirements:
Global mindset and willingness to engage in conference calls at out-of-office hours are required.