Healthcare Quality Compliance Manager

3 days ago

Singapore Flintex Consulting Pte Ltd Full time
Job Description

Opportunity Summary:

We are seeking a seasoned Healthcare Quality Compliance Manager to join our team at Flintex Consulting Pte Ltd. As a key member of our quality assurance team, you will 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 and customer requirements.

Your Key Responsibilities:

  • Determine, implement, and promote policies and procedures for company networks and facilities (hubs & stations) to ensure compliance to standards such as GDP, GCP, and others.
  • Develop and review SOPs and Work Instructions for transportation & fulfillment solutions pertaining to the healthcare industry.
  • Implement compliance and quality programs to support local Quality teams, ensuring they remain up-to-date and prepared.
  • Lead the CAPA process management, including creating and reviewing documentation on corrective and preventive actions and monitoring progress until closure.
  • Develop, implement, and support the Healthcare Quality Management System, develop corresponding training programs, and act as Super User for eQMS system.
  • Contribute to the design and implementation of robust internal audit processes to ensure readiness for various functions and processes when meeting regulatory agencies and customer audits.
  • Lead certification audits with relevant regulatory agencies and certification providers across the region.
  • Conduct regular audit programs/random checks to achieve successful audit outcomes and follow-up actions.
  • Liaise with customers to understand quality requirements/issues/concerns and advise on the way forward, providing guidance based on interpretations applicable to 3PL and supporting issue resolution via root cause analysis.
  • Liaise, consolidate feedback from different functions to update and prepare final copy for Quality Questionnaires, Agreements, and RFQ Proposals for customers.
  • Lead and support validation of transportation lanes and critical equipment like cold chain facilities and packaging systems.

Requirements:

  • 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 industry in a quality-related role.
  • Possess competencies in quality assurance/regulatory affairs, customer relationship management, and root cause analysis.
  • Have working experience ensuring compliance with Goods Manufacturing Practise cGMP, Good Clinical Practices cGCP, Goods Distribution Practice (GDP), ISO13485 for Medical Devices, IATA CEIV, and other local certifications in a warehouse and transportation business.
  • Experience conducting external and internal audits.
  • Must hold at least a Bachelor's degree in Pharmacy from a reputable local institute.

Competencies:

  • Accuracy and attention to detail crucial for proper compliance to 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.

What We Offer:

As a valued member of our team, you can expect a competitive salary of SGD $80,000 - SGD $100,000 per annum, depending on experience, plus benefits and opportunities for professional growth and development.

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