Quality Compliance Specialist (North-East/Healthcare/1 Year Contract/Up to $5500)
Job Description
- 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
- Prepare, review, update, track implement and monitor compliance of standard operating procedures
- Support Quality team in deployment of corporate policy to country local QMS
- Work closely with cross-functional teams in overseeing and providing regulatory/compliance guidance on operational activities (including customer complaints handling and supplier/subcon management)
- Support audit(s) activities including internal audit, external audit, supplier audit and regulatory audit
- 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.
- Support quality compliance improvement programs/projects
- 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
- Serve as the point of the contact in the country on quality compliance matter
- Conduct and support training activities to cross-functional team in the country in alignment with corporate QMS requirements
- Support regional Quality Compliance leader to drive and implement any improvement project in country
- Issue CAPA based on audit findings and follow up through until closure
- Ensure CAPA effectivenes
- Conduct and support activity related to Field Corrective Action (FCA). Ensure timely follow-up, execution and completion of necessary action
- Plan and conduct audit(s) on subcon activity regularly to ensure effectiveness of QMS
- Identify requirements and establish the process for Issue Review and Escalation to division
- 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
- Responsible or the investigation in issue review.
- 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
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