Healthcare Quality Specialist
1 month ago
Join FLINTEX CONSULTING PTE. LTD. as a Healthcare Quality Specialist and play a critical role in driving compliance and quality programs for Healthcare Transportation and facilities. As a key member of our team, you will support the Healthcare Quality Management System to ensure processes and systems are compliant with regional and local regulations and customer requirements.
Key Responsibilities:- Determine, implement, and promote policies and procedures for company Network and facilities (hubs & stations) to ensure compliance to standards such as GDP, GCP, and others.
- Write and review SOPs and Work Instructions for transportation & fulfilment solutions pertaining to the healthcare industry.
- Implement compliance and quality programs to support local Quality teams to ensure they are kept up-to-date and prepared.
- 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.
- Develop, implement, and support the system and processes, develop corresponding training programs, and act as Super User for eQMS system.
- Provide inputs to support the design and implementation of robust internal audit processes to ensure readiness of various functions & processes when meeting regulatory agencies & customer audits.
- Lead and support various certification audits with relevant regulatory agencies and certification providers across the region.
- Lead regular audit programs/random checks to achieve successful audit outcomes and proper post-audit follow-up actions.
- 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).
- Liaise, consolidate feedback from different functions to update and prepare final copy for Quality Questionnaires, Agreements, and RFQ Proposals for customers.
- Lead and support validation of transportation lanes and critical equipment like cold chain facilities, and packaging systems.
- Hold local pharmacist license (and may be required to hold licenses and permits on behalf of the company).
- Have three (3) to five (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, Good Clinical Practises cGCP, Goods Distribution Practice (GDP), and ISO 13485 for Medical Devices, IATA CEIV, and other local certifications in a warehouse and transportation business.
- Experience in conducting external and internal audits.
- Must hold at least a Bachelor's degree in Pharmacy from a reputable local institute.
- Accuracy and attention to detail, which is crucial to proper compliance to regulatory and standards.
- Problem-solving skills to support customer issue resolution.
- Planning and organization skills to ensure proper audit programs are managed effectively.
- Communication skills to facilitate engagements with customers 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.
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