Healthcare Quality Expert
4 days ago
We are seeking an exceptional individual to join our team at FLINTEX CONSULTING PTE. LTD. as a Healthcare Quality Expert. In this critical role, you will drive compliance and quality programs for our clients in the healthcare industry.
About the RoleThis is a hybrid position that offers a unique blend of quality assurance, regulatory compliance, and customer relationship management. As a key member of our team, you will be responsible for ensuring that our processes and systems meet regional and local regulations and customer requirements.
Key Responsibilities:- Determine, implement, and promote policies and procedures to ensure compliance with standards such as GDP, GCP, and others.
- Write and review SOPs and Work Instructions for transportation and fulfilment solutions related to the healthcare industry.
- Implement compliance and quality programs to support local quality teams and ensure they are kept up-to-date and prepared.
- Lead process creation and review of documentation on CAPA implementation and responses, monitor action progress until closure.
- Develop, implement, and support the healthcare quality management system, develop corresponding training programs, and act as a Super User for eQMS.
- Provide inputs to design and implement robust internal audit processes to ensure readiness for regulatory agencies and customer audits.
- Lead certification audits with relevant regulatory agencies and certification providers across the region.
- Lead regular audit programs and random checks to achieve successful audit outcomes and proper post-audit follow-up actions.
To succeed in this role, you will need to hold a local pharmacist license and have three to five years of relevant experience in pharmaceutical or healthcare industry in a quality-related role. You should possess competencies in quality assurance, regulatory affairs, customer relationship management, and root cause analysis.
A strong background in conducting external and internal audits, as well as experience with certifications like cGMP, cGCP, GDP, ISO13485, IATA CEIV, and other local certifications in a warehouse and transportation business, is essential.
You must hold a Bachelor's degree in Pharmacy from a reputable local institute and demonstrate excellent problem-solving skills, planning and organization skills, communication skills, project management capabilities, and data-driven decision-making skills.
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