Healthcare Regulatory Expert

3 days ago

Singapore beBeeCompliance Full time $90,000 - $120,000
Regulatory Compliance Specialist

Job Description:

  • Drive compliance and quality programs for healthcare transportation & facilities, ensuring processes and systems meet regional and local regulations.
  • Develop, implement, and support the healthcare quality management system, including training programs and eQMS system expertise.
  • Lead internal audits and certification audits with regulatory agencies, supporting readiness and successful audit outcomes.
  • Manage CAPA process creation and review, monitoring action progress until closure.
  • Collaborate with customers to understand quality requirements and provide advisory services on 3PL operations.

Required Skills and Qualifications:

  • Bachelor's degree in Pharmacy from a reputable local institute and a pharmacist license.
  • Three to five years of relevant experience in the pharmaceutical or healthcare industry in a quality-related role.
  • Experience working within a warehouse environment is highly desired.
  • Competencies in quality assurance, customer relationship management, root cause analysis, cGMP, GCP, GDP, ISO13485, IATA CEIV, and other local certifications.
  • Experience conducting external and internal audits.

Benefits:

  • Accuracy and attention to detail crucial for proper compliance.
  • Problem-solving skills for customer issue resolution.
  • Planning and organization skills for effective audit program management.
  • Communication skills for engagements with customers and regulatory agencies.
  • Project management capabilities and familiarity with Process Mapping, Six Sigma, Lean Methodology, Agile, or Design Thinking.
  • Data-driven decision-making with data analytics and visualization tools like Power BI and Microsoft Office applications.

Others:

  • Cold Chain, GxP, Healthcare Industry, Warehousing, CAPA, cGMP Manufacturing, cGMP, 3PL, Quality Management, Quality Management Systems, Regulatory Affairs, Healthcare, cGMP Practices, Customer Relationship Management, Audits, Internal Audit Quality Assurance, GCP, Internal Audit, QMS, Quality Management Systems

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