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Healthcare Regulatory and Quality Specialist

4 weeks ago

Singapore Ad Astra Consultants Full time
Overview

A global provider of transportation, e-commerce and business services is seeking a Healthcare Regulatory and Quality Specialist to drive compliance and quality programs for Healthcare Transportation & Facilities and to support the Healthcare Quality Management System to ensure processes and systems comply with regional and local regulations and customer requirements.

Responsibilities
  • Quality Policies & Procedures: Determine, implement & promote policies and procedures for the internal Network and facilities (hubs & stations) to ensure compliance with standards such as GDP, GCP and others.
  • Quality Assessment & Standards: Write & review SOPs and Work Instructions for transportation & fulfilment solutions in the healthcare industry.
  • Compliance & Quality Program Management: Implement compliance and quality programs to support local Quality teams to ensure they are kept up-to-date and prepared.
  • CAPA Process Management: Lead in process creation and review of documentation on the implementation and responses to corrective and preventive actions (CAPAs) and monitor action progress until closure.
  • Healthcare Quality Management System: Develop, implement & support the system and processes, develop related training programs, and acts as Super User for the eQMS system.
  • Internal Audit Programs: Provide inputs to support the design & implementation of robust internal audit processes to ensure the readiness of various functions & processes when meeting regulatory agencies & customer audits.
  • Certification Audits: Lead and support various certification audits with relevant regulatory agencies and regional certification providers.
  • Operations & Customer Audit Programs: Lead regular audit programs / random checks to achieve successful audit outcomes and proper post-audit follow-up actions.
  • Healthcare Customer Liaison: Liaise with customers to understand quality requirements/issues / underlying concerns to advise on the way forward, provide advice based on interpretations as applicable to 3PL and support in issue resolution via conducting root cause analysis (depot).
  • Healthcare Quality Feedback: Liaise and consolidate feedback from different functions to update and prepare the final copy for Quality Questionnaires, Agreements and RFQ Proposals for customers.
  • Validation Programs: Lead and support validation of transportation lanes and critical equipment like cold chain facilities and packaging systems.
Qualifications
  • Bachelor's degree in Pharmacy from a reputable local institute and hold a local pharmacist license.
  • Have 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
  • Have 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 Practises cGCP, Goods Distribution Practice (GDP) & ISO13485 for Medical Devices, IATA CEIV and other local certifications in a warehouse and transportation business.
  • Experience in conducting external and internal audits
  • Accuracy & attention to detail which is crucial to proper compliance with regulatory and standards
  • Problem-solving skills to support customer issue resolution
  • Planning & organization skills to ensure proper audit programs are managed effectively
  • Communication skills to facilitate engagements with customer 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
Seniority level
  • Associate
Employment type
  • Full-time
Job function
  • Quality Assurance, Other, and Supply Chain
Industries
  • Transportation, Logistics, Supply Chain and Storage

Location: Johor Baharu, Johore, Malaysia

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