Healthcare Compliance Specialist

3 weeks ago

Singapore Flintex Consulting Pte Ltd Full time

Job Description
Healthcare Quality & Regulatory Compliance Specialist (Hybrid)


Opportunity:
Play a critical role in driving compliance and quality programs for healthcare transportation and facilities, ensuring processes and systems align with regional and local regulations, as well as customer requirements.


Your Contribution:

  • Determine, implement, and promote policies and procedures for company networks and facilities to ensure compliance with standards such as GDP, GCP, and others.

  • Write and review SOPs and work instructions for transportation and fulfillment solutions pertaining to the healthcare industry.

  • Implement compliance and quality programs to support local quality teams, ensuring they are up-to-date and prepared.

  • Lead process creation and review of documentation on CAPAs and monitor action progress until closure.

  • Develop, implement, and support the healthcare quality management system, including corresponding training programs and serving as a super user for the eQMS system.

  • Provide inputs to support the design and implementation of robust internal audit processes to ensure readiness for regulatory agencies and customer audits.

  • Lead and support various certification audits with regulatory agencies and certification providers across the region.

  • Lead regular audit programs and random checks to achieve successful audit outcomes and proper post-audit follow-up actions.

  • Liaise with customers to understand quality requirements, issues, and concerns and provide advice on the way forward.

  • Liaise, consolidate feedback from different functions, and update and prepare final copies for quality questionnaires, agreements, and RFQ proposals for customers.

  • Lead and support validation of transportation lanes and critical equipment, such as cold chain facilities and packaging systems.


What we look for in you

  • Hold a local pharmacist license and may be required to hold licenses and permits on behalf of the company.

  • Have three to five years of relevant experience in pharmaceutical or healthcare in a quality-related role.

  • Have competencies in quality assurance, regulatory affairs, customer relationship management, and root cause analysis.

  • Have working experience ensuring compliance with Goods Manufacturing Practice (cGMP), Good Clinical Practice (GCP), Goods Distribution Practice (GDP), ISO 13485 for Medical Devices, IATA CEIV, and other local certifications in a warehouse and transportation business.

  • Experience in conducting external and internal audits.

  • Must hold at least a Bachelor's degree in Pharmacy from a reputable local institute.


Your competencies:

  • Accuracy and attention to detail are crucial for proper compliance with regulatory and standards.

  • Problem-solving skills to support customer issue resolution.

  • Planning and organization skills to ensure proper audit programs are managed effectively.

  • Communication skills to facilitate engagements with customers and regulatory agencies.

  • Project management capabilities and familiarity with Process Mapping, Six Sigma, Lean Methodology, Agile, or Design Thinking.

  • Apply data-driven decision-making with the use of data analytics and visualization tools like Power BI and competency in Microsoft Office applications like Excel, Word, and PowerPoint.


Requirements
Healthcare Quality & Regulatory Compliance Specialist

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