Quality Compliance Specialist (Healthcare / North-East / Up to $5000)

Quality Compliance Specialist (Healthcare / North-East / Up to $5000) GDPMDS / ISO13485 / Quality Management System / Auditing / CAPA

Job Description

1. Ensure implementation, monitoring and improving local Quality Management System (QMS) with regulatory compliance across the company in alignment with Healthcare Business Group corporate quality standards and country regulatory requirements
2. Prepare, review, update, track implement and monitor compliance of standard operating procedures
3. Support Quality team in deployment of corporate policy to country local QMS
4. Work closely with cross-functional teams in overseeing and providing regulatory/compliance guidance on operational activities (including customer complaints handling and supplier/subcon management)
5. Support audit(s) activities including internal audit, external audit, supplier audit and regulatory audit
6. Participate in CAPA board meeting to ensure corrective and preventive action is meeting corporate and country regulatory requirements. Ensure timely follow-up, execution, completion of necessary action and review effectiveness of CAPA.
7. Support quality compliance improvement programs/projects
8. Work closely with Management team to improve internal control and governance practices to enhance the effectiveness and efficiency of the operations and process to ensure compliance
9. Serve as the point of the contact in the country on quality compliance matter
10. Conduct and support training activities to cross-functional team in the country in alignment with corporate QMS requirements
11. Support regional Quality Compliance leader to drive and implement any improvement project in country
12. Issue CAPA based on audit findings and follow up through until closure
13. Ensure CAPA effectivenes
14. Conduct and support activity related to Field Corrective Action (FCA). Ensure timely follow-up, execution and completion of necessary action
15. Plan and conduct audit(s) on subcon activity regularly to ensure effectiveness of QMS
16. Identify requirements and establish the process for Issue Review and Escalation to division
17. Leads the Identify and Assess steps within the Issue Review portion of this process. Responsible for documentation and obtaining approvals of the Issue Review Documen
18. Responsible or the investigation in issue review.
19. Other such duties that may be determined by management.

Position Requirements

· Bachelor’s degree in Pharmaceutical, Pharmacy or Science or equivalent

· Has analytical skill, able to interpret information and data for routine operational needs.

· Has good understanding on ISO9001:2015, ISO 13485:2016 or GDP/GDPMD

· Minimum 3-5 years’ experience in Quality function

· Certified ISO 13485 or GDPMD internal auditor is preferred

· Experience with project management is preferred

EA License No. 01C4394 • RCB No. 200007268E •EA Registration No. R22109454 Malcolm Lee Jun Hao

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.