Unison Group

Healthcare Quality & Regulatory Specialist

Unison Group  •  Singapore, SG (Onsite)  •  1 day ago
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Job Description


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 acts as Super User for 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
Unison Group

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
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