Quality System Manager

Position: Quality System Manager
Reporting Manager: Head of Quality (Pharmacist)
Dotted Line: Plant Manager and Senior Quality Director (Expat)
Job Scope: The Quality system Manager serves as the process owner for Quality system/Compliance implementation for Manufacturing facility and leads a team of Quality professionals. The position develops strategies and Annual objectives for the Quality system process which aligns with Company Quality strategy. This role drives successful execution to achieve plant Key performance targets and partner with Manufacturing team to develop and maintain compliant and efficient Quality system. The Quality system manager coaches, develops and mentors Quality system professionals.
Job Details:

• Responsible for all related Quality System for locally Manufactured products in Thailand.
• Responsible for providing leadership and guidance in establishing quality standards and specifications appropriate to Company's Amata plant in Thailand.
• Responsible for working closely with Company Thailand business unit and Supply Chain to meet Company Renal business goals.
• Ensure and responsible for compliance to Company and local Regulatory requirements for manufacturing in Thailand.
• Ensure that the Thai Renal manufacturing site meets Company and Thai GMP requirements.
• Recruit a quality organization to ensure execution of Company Quality system in the Thai renal plant.
• Ensure adequate review and execution of qualification/validation protocols to facilitate robust manufacturing and quality standards.
• 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 with Company's Global Quality Procedures (GQP) and Certificates of Compliance (CoC) program.
• Ensure all new suppliers are properly reviewed, and New Supplier Approval Processes (Quality Agreement, Questionnaire, Facility Audit, GMP Certification are completed) are properly followed.
• Responsible for quality (GMP), ISO13485 and regulatory performance in the department to ensure quality program is met.

Qualifications:

• Bachelor's Degree in Pharmacy and a valid Pharmacist license.
• Background in Quality Management for medical devices, pharmaceutical manufacturing, or commercial business.
• Minimum 8 years of experience in Quality Assurance, Quality Control, Regulatory Affairs, or related fields.
• Demonstrated interpersonal and leadership skills with ability to interface well with other departments and lead effectively and efficiently in a team environment.
• Excellent in English communication skills in both, written and verbal.

Interested candidates please send your application letter with resume, current and expected salary with contact details to:
Attn: Mr. Norachat Wungpingchai - Professional & Executive Consultant
44/59 Moo 11, Nong-prue, Banglamung, Chonburi 20150
Tel. 033 - 135014 ext.3403 or 086-3834349
Manpower recruitment license No.Chobor.03/2554