Pharmacist

1. Supervise the production system, Quality Assurance (QA), and Quality Control (QC) to comply with PIC/S GMP, TFDA GMP, and 21 CFR Part 211 standards.

1. Prepare, review, and approve documents in the quality system, such as SOP, Validation Protocol, Master Batch Record, and Specification in English.

1. Lead or play a key role in preparing for and receiving audits from TFDA, PIC/S, US FDA, or WHO.

1. Prepare and monitor Corrective and Preventive Action (CAPA) plans, as well as investigations of Deviations and Out of Specification (OOS) results.

1. Control production processes and laboratories to comply with TPhap and USP standards.

1. Train personnel on GMP standards and coordinate with relevant regulatory agencies.

Qualifications: Male or Female Bachelor's degree or higher in Pharmacy with a valid Thai Pharmacist License. At least 5 years of work experience in a pharmaceutical manufacturing plant in production management, Quality Assurance (QA), or laboratory (QC). At least 1 instance of direct experience leading or receiving audits (Audit/Certification) from TFDA, PIC/S, WHO, or US FDA. Expertise in PIC/S GMP, TFDA GMP, 21 CFR Part 211 regulations and well-acquainted with TPhap and USP standards. Experience in setting up a new factory or production line will be specially considered. Excellent English communication and documentation skills (proficiency in Chinese will be specially considered).