Senior Quality Systems & Validation Specialist

Detail

　　【Job Description】
　　　　Seeking Quality Specialist with strong experience in qualification & validation (QV) to ensure GMP compliance and support robust quality systems across the site.

　　　　Key responsibilities include:
　　　　　 - Lead and support IQ / OQ / PQ and validation activities (process, cleaning, computerized systems)
　　　　　 - Review and approve validation documents (VMP, URS, DQ, FAT/SAT, etc.)
　　　　　 - Ensure compliance with GMP standards (FDA, EU GMP, ICH)
　　　　　 - Assess Change Controls and define re-validation requirements
　　　　　 - Support and manage CAPA, Change Control, and supplier qualification processes
　　　　　 - Conduct risk assessments (e.g., FMEA, HAZOP) to define validation scope
　　　　　 - Ensure all documentation follows data integrity principles (ALCOA+) and is audit-ready
　　　　　 - Act as Quality SME during audits and regulatory inspections
　　　　　 - Maintain SOPs and support GMP / GDocP training across the site
　　　　　 - Drive continuous improvement in validation and quality systems

　　【Qualification】
　　　　 - Minimum of a B.Sc. in Engineering, Applied/Pharmaceutical Sciences, or a related field. Being a licensed Thai pharmacist is considered an asset.
　　　　 - Minimum 5 years of Quality experience in a GMP-regulated environment.
　　　　 - Minimum 3 years dedicated to validation/qualification oversight.
　　　　 - Expertise in cGMP requirements (EU, US FDA, ICH, ISO).
　　　　 - Proven track record in reviewing protocols for HVAC, purified water, and manufacturing equipment.
　　　　 - Proficiency in technical writing and computing (Microsoft Office, Minitab).
　　　　 - Languages: Proficient in English communication (both oral and written).
　　　　 - Detail-oriented, self-motivated, and capable of collaborating across multi-functional disciplines.

　　【Allowance & Benefit】
　　　　 - Provident fund
　　　　 - Medical coverage (OPD/IPD)
　　　　 - Lunch provided
　　　　 - Uniform provided

　　【Working Hour】
　　　　Mon - Fri（07.30-16.00）