AI Success™

Job Description

Position Summary
This position plays 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
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 acts as Super User for eQMS system.
6. Internal Audit Programs: Design & implement robust internal audit processes to ensure readiness of various functions & processes when meeting regulatory agencies & customer audits.
7. Certification Audits: Lead various certification audits with relevant regulatory agencies and certification providers across the region.
8. 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.
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 resolve issues via conducting root cause analysis.
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 the validation of transportation lanes and critical equipment like cold chain facilities, and packaging systems.
12. Depot Support: Provide secondary / backup support to healthcare specialists for market depots.
Requirements :
1. Hold local pharmacist license
2. Have at least 5 -7 years of relevant experience in warehouse, quality + QMS for pharmaceutical / healthcare industry in quality related role
3. Experience working in warehouse is desire
4. Have competencies in quality assurance / regulatory affairs, customer relationship management and root cause analysis
5. Have working experience ensuring compliance in accordance to Goods Manufacturing Practise cGMP,)/, Good Clinical Practises cGCP, Goods Distribution Practice (GDP) & ISO13485 for Medical Devices,
6. Experience in local certifications in a warehouse and transportation business.
7. IATA CEIV certification knowledge would be at advantage but not necessary.
8. Experience in conducting external and internal audits for regions
9. Must hold at least Bachelor’s degree in Pharmacy from a reputable local institute in Singapore.
10. Occasionally travel is required to sites and region warehouses.
Competency
1. Accuracy & attention to detail which is crucial to proper compliance to regulatory and standards
2. Problem-solving skills to support customer issue resolution
3. Planning & organization skills to ensure proper audit programs are managed effectively
4. Communication skills to facilitate engagements with customer and regulatory agencies
5. Project management capabilities and familiarity with Process Mapping, Six Sigma, Lean Methodology, Agile or Design Thinking
6. 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

About Unison Group

Unison Consulting was launched in Singapore on September 2012, the hub of the financial industry, with innovative visions in the technocratic arena. We are a boutique next-generation Technology Company with strong business-interests in Liquidity risk, Market Risk, Credit Risk and Regulatory Compliance.

Unison provides technology consulting and services to implement Risk Management and Risk Analytics System for Financial Institutions. Our services suite comprises of Techno-Functional consulting, systems integration, Business Intelligence, information management, and custom development of IT solutions, plus project management expertise for financial institutions.

We have expertise in latest cutting edge technology to achieve better total cost of ownership. Through our qualified professionals, we assist you drive your unique risk management strategies, whether that means efficient monitoring, improving risk appetite of the financial institutions, complying with regulations, or capturing growth opportunities through innovation, this is what maximizes your decision taking potential. At Unison Consulting, we view clients as partners, and our success is only measured by the success of our partners. So we put it all on the table in order to exceed expectations.

Our staff consists of young, energetic and innovative consultants who are never afraid to challenge the conventions and push the boundaries in an effort to help our clients. For every project, no matter how large or how small, we strive to not only meet your needs, but deliver a showcase in your field.

Industry

IT & Software

Company Size

51-200 employees

Headquarters

Unknown

Year Founded

2012

Website

com.sg

Social Media

Healthcare Quality & Regulatory Advisor - APAC

Job Description

About Unison Group