Quality Management Specialist

Quality Advisor

Play a leading role in managing the Healthcare Quality Management System and implementing compliance programs for Transportation and Healthcare facilities to ensure process, procedures and systems are compliant with regional and local regulations and customer requirements.

The role

• Quality Assessment & Standards : Review SOPs and Work Instructions for transportation & fulfillment solutions pertaining to the healthcare industry.
• Quality Policies : Design, implement & promote policies and procedures for company-wode Network and facilities (hubs & stations) to ensure compliance to standards such as GDP, GCP and others.
• Healthcare Quality Management System : Develop, implement & manage the system and develop corresponding training programs.
• Quality Management : Review documentation on the implementation and responses to corrective and preventive actions (CAPAs) and monitor action progress.
• Quality Audit Processes : Design & implement robust internal audit processes to ensure readiness of various functions and processes when audited by regulatory agencies and customer auditors.
• Certification & Customer Audits : Lead various certification audits with relevant regulatory agencies and certification providers across the region.
• Operations Audit Programs : Lead and conduct External and Vendor 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 and support in issue resolution.

Experience

Soft skills

Skills Required

Root Cause Analysis, Power Bi, Cgmp, Customer Relationship Management, Regulatory Affairs, Data Analytics, Quality Assurance