Healthcare Compliance and Quality Manager

1 week ago

Singapore beBeeHealthcare Full time $90,000 - $120,000

As a Quality Assurance Professional, you will be responsible for driving compliance and quality programs across Healthcare Transportation & Facilities. Your goal will be to ensure that processes and systems are in line with regional and local regulations as well as customer requirements.

Key Responsibilities:
  • Quality Policies & Procedures: Develop, implement, and promote policies and procedures for transportation & facilities to ensure compliance with standards such as GDP, GCP, and others.
  • Quality Assessment & Standards: Write and review SOPs and Work Instructions for transportation & fulfillment solutions pertaining to the healthcare industry.
  • Compliance & Quality Program Management: Implement compliance and quality programs to support local Quality teams in ensuring they are up-to-date and prepared.
  • CAPA Process Management: Lead 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, and support the system and processes, develop corresponding training programs, and act as Super User for eQMS system.
  • Internal Audit Programs: Provide inputs to support the design and implementation of robust internal audit processes to ensure readiness of various functions & processes when meeting regulatory agencies and 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/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.
  • 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 with Goods Manufacturing Practise cGMP/Goods Distribution Practice (GDP) for Medical Devices and other local certifications in a warehouse and transportation business.
  • IATA CEIV desired but not necessary.
  • Familiar with drugs control and secondary labeling 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

Skills: Cold Chain, Healthcare Industry, CAPA, 3PL, Quality Management, Regulatory Affairs, Healthcare, Root Cause Analysis, Customer Relationship Management, Program Management, Process Management, Medical Devices, Audits, GCP, Manufacturing, Audit

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