Healthcare Quality Assurance Specialist

2 months ago

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

As a pivotal contributor to the Healthcare Quality Management System, you will oversee compliance and quality initiatives for healthcare transportation and facilities, ensuring adherence to regional and local regulations as well as customer specifications.

Key Responsibilities:

Policy Development:

Establish, implement, and advocate for policies and procedures across the company’s network and facilities to guarantee compliance with standards such as Good Distribution Practice (GDP) and Good Clinical Practice (GCP).


Quality Documentation:

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


Compliance Program Implementation:

Develop and manage compliance and quality programs to assist local Quality teams in maintaining current practices and readiness.


Corrective Action Management:

Spearhead the creation and review of documentation for corrective and preventive actions (CAPAs), monitoring progress until resolution.


Quality Management System Support:

Design, implement, and support the Quality Management System, including developing training programs and serving as a Super User for the electronic Quality Management System (eQMS).


Internal Audit Coordination:

Contribute to the design and execution of comprehensive internal audit processes to ensure preparedness for regulatory and customer audits.


Regulatory Audits:

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


Operational Audits:

Conduct regular audit programs and random checks to ensure successful audit outcomes, followed by appropriate post-audit actions.


Client Quality Liaison:

Engage with clients to identify quality requirements and concerns, providing guidance and support in issue resolution through root cause analysis.


Quality Feedback Management:

Collect and consolidate feedback from various departments to prepare final versions of Quality Questionnaires, Agreements, and RFQ Proposals for clients.


Validation Initiatives:

Oversee and support 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 3 to 5 years of relevant experience in the pharmaceutical or healthcare sector in a quality-focused role.
  • Demonstrate expertise in quality assurance, regulatory affairs, customer relationship management, and root cause analysis.
  • 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.
  • Proficient in conducting both external and internal audits.
  • Hold at least a Bachelor's degree in Pharmacy from a recognized institution.
Essential Skills:
  • Strong attention to detail and accuracy to ensure compliance with regulations and standards.
  • Effective problem-solving abilities to assist in customer issue resolution.
  • Excellent planning and organizational skills for managing audit programs efficiently.
  • Strong communication skills for engaging with clients and regulatory bodies.
  • Project management skills with familiarity in 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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