Analytical Development Section Manager

Interthai Pharmaceutical Manufacturing Ltd.

Interthai Pharmaceutical Manufacturing Ltd. (Chatuchak)

Chatuchak

Bangkok, Thailand

We are International Manufacturing Company having more than 500 employees in Thailand plant with more than 40 years reputation in Pharmaceutical Manufacturing Industry in Thailand and in Asia Pacific. With the requirement of our business development and our continuous growth in Thailand market as well as in Asia Pacific region, we are now searching for competent, enthusiastic and highly qualified candidates for the following challenging position:

About this position

The Analytical Development Section Manager is responsible for overseeing quality control of new projects, analytical method development, and ensuring compliance with regulatory requirements while managing resources effectively.

Responsibilities

• Responsible for quality control of new projects, including analytical method development, raw materials and finished products, as assign to meet target timeline as company requirement.
• Responsible for Analytical method Validation and stability study of new products, existing products, material including cost evaluation.
• Responsible for ACTD document preparation for new products, variation or registration renewal for submission to FDA as regulation as target timeline.
• Management resources, including human resources and Lab instrument capacity for supporting new products for achieved timeline target.
• Enforces company policies: GMP, GLP, ISO9001, Safety, ISO/IEC17025 and personnel discipline.
• Manage developing or improving of analytical method for new products or existing products.
• Provide analytical monograph and specification for both raw material and finished product.
• Provide analytical method Validation report and stability study report including cost evaluation.
• Provide required documents and accompany revising to support new product registration.
• Provide and arrange resources to handle all requests for analytical development.
• Provide procedure of operation to ensure systematical control.
• Improve efficiency of all resources.
• Coordinate with the Principal or third-party lab for proficiency testing/interlaboratory comparison.
• Prepare/quality subcontract testing lab and service contractors in new testing/service.
• Prepare finished product specification, master certificate of analysis and analysis report.
• Review stability protocol and follow up stability test schedule to complete in timely manner.

Requirements

• Bachelor's degree in chemistry or pharmacy.
• Experience 3-5 years.