Healthcare Regulatory

Roles & Responsibilities

My Client is a global provider of transportation, e-commerce and business services. In this role, you will be critical in driving compliance and quality programs for Healthcare Transportation & Facilities and supporting the Healthcare Quality Management System to ensure processes and systems comply with regional and local regulations and customer requirements.

What you'll do:

• Quality Policies & Procedures: Determine, implement & promote policies and procedures for internal Networks 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 pertaining to 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 corresponding 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 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.

What you'll need:

• Bachelor's degree in Pharmacy from a reputable local institute and a 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 in accordance to 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

Competencies:

• 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

Tell employers what skills you have

Cold Chain
GxP
Healthcare Industry
Warehousing
CAPA
cGMP Manufacturing
cGMP
3PL
Quality Management
Quality Management Systems
Regulatory Affairs
Healthcare
cGMP Practices
Customer Relationship Management
healthcare experience
Audits
Internal Audit Quality Assurance
GCP
Internal Audit
QMS, Quality Management Systems

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