Quality Manager/Senior Quality Manager

• Provide leadership role to lead Quality Management function in Thailand.
• Responsible for all related Quality Assurance and Quality control responsibility for locally Manufactured products in Thailand.
• Responsible for providing leadership and guidance in establishing quality standards and specifications appropriate to Baxter’s Renal plant in Thailand.
• Responsible for working closely with Baxter Thailand business unit and Supply Chain to meet Baxter Renal business goals.
• Ensure and responsible for compliance to Baxter and local Regulatory requirements for manufacturing in Thailand.
• Ensure that the Thai Renal manufacturing site meets Baxter and Thai GMP requirements.
• Recruit a quality organization to ensure execution of Baxter Quality system in the Thai renal plan.
• Ensure adequate review and execution of qualification/validation protocols to facilitate a robust manufacturing and quality standard.
• Establish a robust quality system with adequate procedures to ensure compliance always.
• Analyze and advise on required process changes and implementation, and provide training, tools and techniques to enable others to achieve quality.
• Ensure compliance to Baxter’s Global Quality Procedures (GQP) and Certificates of Compliance (CoC) program.
• Responsibilities to maintain a system or have some shared, or jointly exercised, responsibility relating to quality. These may include, subject to any national regulations.

Qualifications:

• Bachelor of Pharmacy, must obtain Pharmacist license.
• Background in Quality Management for Medical Devices or Pharmaceutical Manufacturer.
• At least 10 years in Quality Assurance, Quality Control, Regulatory Affairs and related.
• Well knowledgeable in PIC/S Regulation and working with Ministry of Health.
• Excellent in English communication skills in both, written and verbal. (Reporting to Foreign Regional Director)