Quality Assurance Specialist

2 days ago

Singapore beBeeCompliance Full time $60,000 - $80,800
Quality Assurance Specialist

Our organization seeks a dedicated Quality Assurance Specialist to ensure compliance with regulatory requirements and corporate policies. This role plays a vital part in guaranteeing adherence to Good Manufacturing Practice (GMP), ISO standards, and Standard Operating Procedures (SOP).

Key Responsibilities:
  • Ensure the organization's quality systems meet applicable federal, state, and local regulations as well as corporate policies.
  • Perform assessments of site and cross-site quality systems to maintain high levels of compliance.
  • Review SOPs, protocols/batch records, reports, and quality and regulated records involving technically complex issues and processes for accuracy and compliance.
  • Participate in identifying recommendations to Operations and Quality Management for improvements in auditing quality systems.

This position also involves preparing study and QA files for sponsor site visits and regulatory inspections. Additionally, you will assist in developing recommendations for corrective and preventative actions to respond to client visit and regulatory inspection findings.

We are strategically positioned to coordinate worldwide resources and apply multidisciplinary perspectives in resolving our clients' unique challenges. Our diverse portfolio of discovery and safety assessment services enables our clients to create a more flexible drug development model, reducing costs, enhancing productivity, and increasing speed to market.

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