Healthcare Quality & Regulatory Specialist ( APAC)

Flintex Consulting Pte Ltd; Singapore; On-site; SGD 60,000 - 95,000; Full time

Job summary

Ein etabliertes Unternehmen im Gesundheitswesen sucht einen erfahrenen Qualitätsmanager, der für die Umsetzung und Überwachung von Compliance- und Qualitätsprogrammen verantwortlich ist. In dieser Schlüsselrolle stellen Sie sicher, dass die Prozesse und Systeme den regionalen und lokalen Vorschriften entsprechen. Sie werden die Entwicklung und Unterstützung des Healthcare Quality Management Systems leiten und als Ansprechpartner für Kunden fungieren, um deren Qualitätsanforderungen zu verstehen und zu erfüllen. Wenn Sie eine Leidenschaft für Qualität und Compliance haben und in einem dynamischen Umfeld arbeiten möchten, ist dies die perfekte Gelegenheit für Sie.

Benefits

13. Monatsgehalt

Anreize (2-3 Monate)

Einstiegs- und Bindungsbonus

Qualifications

• Mindestens 5-7 Jahre Erfahrung im Bereich Qualität und QMS in der pharmazeutischen Industrie.
• Lokale Apothekerlizenz erforderlich.
• Erfahrung in der Durchführung interner und externer Audits.

Responsibilities

• Implementierung von Compliance- und Qualitätsprogrammen zur Unterstützung lokaler Qualitäts-Teams.
• Entwicklung und Unterstützung des Healthcare Quality Management Systems.
• Leitung von Zertifizierungsaudits mit relevanten Aufsichtsbehörden.

Skills

Qualitätsmanagementsysteme (QMS)

Regulatorische Angelegenheiten

Kundenbeziehungsmanagement

Ursachenanalyse

Prozessmanagement

Education

Bachelor in Pharmazie

Tools

Power BI

Microsoft Office (Excel, Word, PowerPoint)

Job description

Benefits: 13th Month Salary, Incentives (2-3months), Joining and Retention Bonus

Position Summary

This position play a critical role in driving 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.

Job Scope

• 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: Design & implement robust internal audit processes to ensure readiness of various functions & processes when meeting regulatory agencies & customer audits.

• Certification Audits: Lead various certification audits with relevant regulatory agencies and certification providers across the region.

• Operations & Customer Audit Programs: Lead & prepare for regular audit programs / random checks / regulatory activities 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 resolve issues 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 the validation of transportation lanes and critical equipment like cold chain facilities, and packaging systems.

• Depot Support: Provide secondary / backup support to healthcare specialists for market depots.

Requirements :

• Hold local pharmacist license

• Have at least 5 -7 years of relevant experience in warehouse, quality + QMS for pharmaceutical / healthcare industry in quality related role

• Experience working in warehouse is desire

• 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) & ISO13485 for Medical Devices,

• Experience in local certifications in a warehouse and transportation business.

• IATA CEIV certification knowledge would be at advantage but not necessary.

• Experience in conducting external and internal audits for regions

• Must hold at least Bachelor’s degree in Pharmacy from a reputable local institute in Singapore.

• Occasionally travel is required to sites and region warehouses.

Competency

• Accuracy & attention to detail which is crucial to proper compliance to regulatory and standards

• Problem-solving skills to support customer issue resolution

• Planning & organization skills to ensure proper audit programs are managed effectively

• Communication skills to facilitate engagements with customer and regulatory agencies

• Project management capabilities and familiarity with Process Mapping, Six Sigma, Lean Methodology, Agile or Design Thinking

• Apply data-driven decision making with the use of data analytics and visualization tools like Power BI and competency in Microsoft Office applications like Excel, Word, and PowerPoint

Working Hours : Mon to Fri 9am-6pm