Our client is an international bio-pharmaceutical company with strong growth and expansion globally.

職務說明

• Ensure alignment with current strategic initiatives identified by RA/QA and inter-functional groups (e.g. SOPs, Training, QA Program, Company Regulatory Compliance), and those priorities, identified by area or local management team.
• Develop and Implement local SOPs, systems, and training program.
• Collaborate with International Audit Groups and support Medical, Regulatory, and Quality Assurance inspections.
• Support cross-functional quality-related initiatives and facilitate quality awareness outside the Regulatory Affairs & Quality Assurance Team.
• Assist with providing introduction/orientation to the new hires of Regulatory Affairs and Quality Assurance Team.
• Handle GMP Clearance and liaise with local Regulatory Health Authority.
• Liaise and negotiate with internal and external stakeholders.
• Proficient in a variety of specialized computer applications relevant to Quality Assurance.
• Stay abreast of all regulations to ensure the compliance of documentation.

理想的應徵者

• Bachelor or master's degree in scientific discipline is required.
• QA experiences in pharmaceutical industry is preferred. Knowledge in medical device is ideal but not mandatory.
• Proactive, independent and responsible working attitude.
• Good command of English in speaking and writing.
• Possess detailed knowledge of Taiwan registration requirements, including the understanding of relevant legislation, guidelines and process, locally and internationally.
• Excellent organizational skills and ability to meet deadlines.
• Exceptional self-management ability.

福利待遇

Take the chance to partner with a fast-expanding business backed up by industry leaders and bring your career to the enxt level.

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