Job Detail
About this Job
Purpose and objectives:
We seek talented, energetic, and self-driven people to join our professional team. Our environment is both challenging and supportive. We give employees the opportunity to develop their skills and do their best work.
Responsibility:
• Releasing the imported and exported product to the marketing as well as the handling of QA activities such as Deviation, Recall, Complaint, Change control and etc. to ensure the quality of product and comply with standards & regulation.
• Prepares reviews and compiles necessary data, scientific reports, and written submission contributions for the Chemistry, Manufacturing, and Controls to meet ASEAN CTD.
• Guides Manufacturing in developing data and strategy for gaining approvals for post-marketing changes.
• Interfaces with CMC and Quality Assurance based on ICH or European GMP requirements.
• Performs other duties as assigned
Qualification:
• Thai nationality only, Aged not over 30 years old
• Requires Bachelor Degree in Pharmacy with at least 2 years of direct experiences in pharmaceutical manufacturing process or/and GMP related principles.
• Directly related experience in any of following will be advantage: Quality Control, Quality Assurance, or Pharmaceutical Manufacturing.
• Internal and external GMP auditing
• Dealing with complex CMC regulatory issues and requirements.
• Capable of product developing and handling QA related project
• Effective communications skills, Team player, Open & Positive mind.
• Good command of both spoken and written English plus Computer business applications.
• Able to travel regularly
*English: Business Level (TOEIC: 700)
About the Benefit
- 2 months bonus (Depends on corporate profit)
- Accidental and Health insurance
- Annual Health Check
