Healthcare Quality & Regulatory Compliance Specialist - Global logistics Client - Changi - ref. u18129919

apartmentFlintex Consulting Pte Ltd placeChangi scheduleFull-time calendar_month17/10/25

Benefits : AWS, Incentives (2-3months), Joining and Retention Bonus

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:

Quality Policies & Procedures:

Determine, implement & promote policies and procedures for Company’s Network and facilities (hubs & stations) to ensure compliance to 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 eQMS system.

Internal Audit Programs:

Provide inputs to support the design & implementation of robust internal audit processes to ensure readiness of various functions & processes when meeting regulatory agencies & customer audits

Certification Audits:

Lead and support various certification audits with relevant regulatory agencies and certification providers for the depot.

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, 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

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

starFeatured

Programme Management Executive (Operations & Regulatory Compliance) - Pasir Ris - ref. y84261615

apartmentSingapore Chinese Chamber Institute of BusinessplacePasir Ris, 5 km from Changi

Key Roles and Responsibilities Programme Management • Process and manage enrolled learners’ full journey under WSQ/Non-WSQ programmes • Managing assigned course portfolio encompassing individual and corporate enrolments • Assist in the coordination...

check_circleNew offer

Product Compliance & Risk Senior Manager - APAC Regulatory Controls - Pasir Ris

apartmentWise PaymentsplacePasir Ris, 5 km from Changi

and what we offer. Job Description Salary range: SGD 13,000 - 16,500 per month + RSUs Product Compliance & Risk Senior Manager - APAC Regulatory Controls We’re looking for a Product Compliance & Risk Senior Manager to join our growing Product Compliance...

local_fire_departmentUrgent

GRIT: Group Legal and Compliance, Group Regulatory Compliance - Geylang

apartmentOVERSEA-CHINESE BANKING CORPORATION LIMITEDplaceGeylang, 14 km from Changi

Why Join Shape the future of banking with OCBC’s Group Legal & Compliance. As a Regulatory Compliance Trainee, you’ll be at the heart of ensuring our bank operates with integrity and adheres to evolving regulations. You’ll gain invaluable...