Healthcare Quality & Regulatory Specialist

FLINTEX CONSULTING PTE. LTD.; Singapore; On-site; SGD 50,000 - 70,000; Full time

Job summary

A healthcare compliance company in Singapore is seeking a Quality Manager to drive compliance and quality programs for Healthcare Transportation. The ideal candidate must hold a local pharmacist license and have 3-5 years of experience in quality roles within the pharmaceutical or healthcare industry. Responsibilities include implementing quality procedures, conducting audits, and managing compliance programs, ensuring adherence to regulatory standards.

Qualifications

• Hold a local pharmacist license.
• 3-5 years of relevant experience in quality-related roles in healthcare.
• Competencies in quality assurance and regulatory compliance.

Responsibilities

• Implement quality policies and procedures for compliance.
• Write and review SOPs for healthcare transportation.
• Lead CAPA process management and internal audits.

Skills

Quality assurance

Regulatory affairs

Customer relationship management

Root cause analysis

Education

Bachelor’s degree in Pharmacy

Job description

Overview

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: 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
2. Quality Assessment & Standards: Write & review SOPs and Work Instructions for transportation & fulfilment solutions pertaining to the healthcare industry
3. Compliance & Quality Program Management: Implement compliance and quality programs to support local Quality teams to ensure they are kept up-to-date and prepared.
4. 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.
5. Healthcare Quality Management System: Develop, implement & support the system and processes, develop corresponding training programs, and act as Super User for the eQMS system.
6. 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
7. Certification Audits: Lead and support various certification audits with relevant regulatory agencies and certification providers for the depot.
8. Operations & Customer Audit Programs: Lead regular audit programs / random checks to achieve successful audit outcomes and proper post audit follow up actions.
9. 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).
10. Healthcare Quality Feedback: Liaise, consolidate feedback from different functions to update and prepare final copy for Quality Questionnaires, Agreements and RFQ Proposals for customers.
11. 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