QA Regulatory Compliance Specialist (Must have SG Pharma Licence) - Hiring Immediately

Position: Healthcare Quality & Regulatory Compliance Specialist

Key Responsibilities:

1. Quality Policies & Procedures: Determine, implement & promote policies and procedures for the company 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 & fulfillment 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 across the region.
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.

Technical Skills and Experience Required:

1. Hold local pharmacist license (and may be required to hold licenses and permits on behalf of the company)
2. Have three (3) to five (5) years of relevant experience in pharmaceutical or healthcare industry in a quality related role
3. Have competencies in quality assurance / regulatory affairs, customer relationship management, and root cause analysis
4. Have working experience ensuring compliance in accordance with Good Manufacturing Practice (cGMP), Good Clinical Practice (cGCP), Good Distribution Practice (GDP) & ISO 13485 for Medical Devices, IATA CEIV, and other local certifications in a warehouse and transportation business
5. Experience in conducting external and internal audits
6. Must hold at least Bachelor’s degree in Pharmacy

Interested candidates may apply through the application system. We regret to inform only shortlisted candidates will be notified.

EA License No. 01C4394 • RCB No. 200007268E •Derrick Tiew Yong Han EA Registration No. R1877971

By sending us your personal data and curriculum vitae (CV), you are deemed to consent to PERSOLKELLY Singapore Pte Ltd and its affiliates to collect, use and disclose your personal data for the purposes set out in the Privacy Policy available at https://www.persolkelly.com.sg/policies. You acknowledge that you have read, understood, and agree with the Privacy Policy.