Healthcare Quality & Regulatory Specialist

This role is responsible to drive compliance and quality programs for Healthcare Transportation & Facilities and supporting the Healthcare Quality Management System to ensure processes and systems are compliant with regional and local regulations and customer requirements.

Responsibilities:

1. Quality Policies & Procedures:

1. Quality Assessment & Standards:

1. Compliance & Quality Program Management:

1. CAPA Process Management:

1. Healthcare Quality Management System:

1. Internal Audit Programs:

1. Certification Audits:

1. Operations & Customer Audit Programs:

1. 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).

1. Healthcare Quality Feedback:

1. Validation Programs:

Lead and support validation of transportation lanes and critical equipment like cold chain facilities, and packaging systems

Requirements :

• Hold local pharmacist license
• Have 3-5 years of relevant experience in pharmaceutical or healthcare industry in a quality related role
• 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) for Medical Devices and other local certifications in a warehouse and transportation business.
• IATA CEIV will be desired but not necessary.
• Familiar with drugs control and secondary labelling system
• Experience in conducting external and internal audits
• Must hold at least Bachelor’s degree in Pharmacy from a reputable local institute.

Working hours:

Mon to Fri 9am-6pm