Responsibilities:

• Develop & Maintain high standard quality systems, divisional policies/procedures and regulations related to quality for company
• Ensure local affiliate QA policies and procedures are up-to-date in accordance with applicable external local requirements/regulations and in accordance with the company global procedures.
• Ensure compliance of validation requirements for Affiliate processes, systems (including Quality related computer systems) and distribution centers. Review and approve master validation plans an validation protocols.
• Monitor status of complaints reports. Review complaint data regularly identifying trends for continuous improvement & preventative actions. Liaise closely with Medical advisor/Scientific Affairs manager/Regulatory manager and Safety Officer on issues.
• Participate in QA projects with global QA as required
• Keep up to date with current best practice and guidelines relevant to the role
• Conduct QA internal audits & facilitate/direct all external audits/regulatory inspections.
• Support and coordinate Third Party warehouse (TPW) operations.
• Effective communications to manufacturing facilities to include performance metrics

Qualification:

• Female or Male, Bachelor Degree or higher in Pharmaceuticals or any related field
• At least 3 years experience in a Quality Assurance
• Excellent communication skills both Thai and English
• Good knowledge and experience of GDP, GMP, and People Management
• Hands on / hard working / strong work ethic