Job Purpose:
Responsible for implement and doing maintain warehouse and distribution processes in accordance with applied Gx P standards (GMP, GDP, GHP, etc.) and HACCP

• Be the point of contact for Quality matters with the assigned CMOs. Accountable for establishing and maintaining an effective working relationship with the key contacts at each of the assigned CMOs. These include key contacts with (but are not limited to) Quality, Regulatory, Business Development, Production and others.
• Ensure that all aspects of the products at assigned CMOs comply with the requirements of the ED QMS and meet relevant c GMP regulatory and legislative requirements, through defined key performance and quality indicators.
• Evaluate effectiveness of the CMO’s Quality Unit and systems. Escalate all serious c GMP/Regulatory compliance issues. Monitor the quality performance of the CMOs driving remedial action where necessary. Monitor and assess CMOs key performance indicators.
• Support local QMS (change control, deviations, CAPAs…) of CMOS as required.
• Be the center between ED and CMOs for all related work for products quality, working standard etc.
• Accountable to report status of ongoing activities to upper manager and ED.
• Other tasks assigned by the supervisor
• New product project management
• Maintain and service quality by completing company, standards, system, compliance, and surveillance audits, investigating customer complaints.
• Responsible for receiving any information related to Vigilance issue.

Qualifications:-

• Bachelor’s degree in Pharmaceutical Science
• Minimum 5 years experience in the local pharmaceutical manufacturing company with an emphasis on Quality Assurance or Research and Development or Production is a must.
• Understanding of c GXPs, Quality systems and regulations (Thai FDA) or other geographies’ regulations is a must,
• Project Management skills.
• Demonstrated sound decision-making process; based on facts & data.
• Demonstrated ability to effectively prioritize work.
• Ability to clearly articulate complex situation into resolution by providing path forward to the upper management.
• Strong interpersonal and negotiation skills; with demonstrated ability to influence stakeholders.
• Strong problem-solving skills, with a disposition for continuous improvement.
• Demonstrated ability to work and collaborate in cross-functional teams.
• Demonstrated intercultural skills. Capability to work with diverse and wide spread team.
• Demonstrated commercial acumen to effectively work with external companies.
• Ability to adapt, anticipate issues, work under uncertainty and accommodate flexible work demands.
• Capable of working independently. Ability of good judgments and to make independent decisions.
• Good command of written and spoken English.
• Good Computer literacy (MS Office, MS Outlook).
• Knowledge of technical aspects of drug release testing, HPLC knowledge is an advantage

Pacific Healthcare (Thailand) Co., Ltd.,
People and Culture Department
1011 Supalai Grand Tower, Room No.01, 29 th Fl., Rama 3 Rd., Chongnonsee, Yannawa, Bangkok 10120
E-mail: recruit@phc.co.th
Website: www.phc.co.th
Only successful applications will be contacted.