Healthcare Quality Assurance Specialist

2 months ago

Singapur, Singapore Flintex Consulting Pte Ltd Full time
Position Overview:

The Healthcare Quality & Regulatory Compliance Specialist plays a pivotal role in ensuring adherence to quality standards and regulatory requirements within Healthcare Transportation and facilities. This position supports the Healthcare Quality Management System to guarantee that all processes align with regional and local regulations as well as customer expectations.

Key Responsibilities:

Quality Policies & Procedures:

Develop, implement, and advocate for policies and procedures across the company’s network and facilities (hubs & stations) to maintain compliance with standards such as GDP, GCP, and others.


Quality Assessment & Standards:

Draft and review Standard Operating Procedures (SOPs) and Work Instructions related to transportation and fulfillment solutions in the healthcare sector.


Compliance & Quality Program Management:

Execute compliance and quality initiatives to assist local Quality teams in remaining current and prepared.


CAPA Process Management:

Oversee the creation and evaluation of documentation concerning the implementation and responses to Corrective and Preventive Actions (CAPAs), ensuring action progress is monitored until resolution.


Healthcare Quality Management System:

Design, implement, and support the Quality Management System and associated processes, develop relevant training programs, and serve as the Super User for the electronic Quality Management System (eQMS).


Internal Audit Programs:

Contribute to the design and execution of comprehensive internal audit processes to ensure various functions and processes are prepared for regulatory and customer audits.


Certification Audits:

Lead and facilitate various certification audits with relevant regulatory bodies and certification organizations across the region.


Operations & Customer Audit Programs:

Conduct regular audit programs and random checks to achieve favorable audit results and ensure appropriate follow-up actions post-audit.


Healthcare Customer Liaison:

Engage with customers to comprehend quality requirements, address issues, and provide guidance based on interpretations relevant to third-party logistics (3PL), facilitating issue resolution through root cause analysis.


Healthcare Quality Feedback:

Gather and consolidate feedback from various functions to prepare and finalize Quality Questionnaires, Agreements, and RFQ Proposals for clients.


Validation Programs:

Lead and assist in the validation of transportation routes and critical equipment, including cold chain facilities and packaging systems.


Qualifications:
  • Possess a local pharmacist license (may be required to hold licenses and permits on behalf of the company).
  • Have three (3) to five (5) years of relevant experience in the pharmaceutical or healthcare industry in a quality-focused role.
  • Demonstrate expertise in quality assurance, regulatory affairs, customer relationship management, and root cause analysis.
  • Have experience ensuring compliance with Good Manufacturing Practices (cGMP), Good Clinical Practices (cGCP), Good Distribution Practices (GDP), ISO 13485 for Medical Devices, IATA CEIV, and other local certifications in a warehouse and transportation environment.
  • Experience in conducting both external and internal audits.
  • Hold at least a Bachelor's degree in Pharmacy from a recognized local institution.
Essential Competencies:
  • Meticulous attention to detail, crucial for compliance with regulatory standards.
  • Strong problem-solving abilities to aid in customer issue resolution.
  • Effective planning and organizational skills to manage audit programs efficiently.
  • Excellent communication skills to engage with customers and regulatory agencies.
  • Project management skills, familiar with Process Mapping, Six Sigma, Lean Methodology, Agile, or Design Thinking.
  • Ability to apply data-driven decision-making using data analytics and visualization tools such as Power BI, along with proficiency in Microsoft Office applications like Excel, Word, and PowerPoint.

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