PV Quality Assurance Lead — Training, Audits & CAPA

Celltrion Inc; Taguig; On-site; PHP 900,000 - 1,300,000; Full time

Job summary

Celltrion Inc in the Philippines seeks a Quality Assurance Specialist to strengthen the PV Quality Management System and serve as a subject-matter expert in PV QA. You will partner with PV Operations to prevent, detect, and correct quality issues while driving continuous improvement aligned with GVP, ICH, EMA, and FDA expectations.

The role covers QMS management, training oversight in ELMS, audits & inspections support, deviation & CAPA leadership, and cross-functional collaboration to maintain

Qualifications

• 3-5 years professional PV experience, including QA.
• Fluent in English; additional languages are a plus.
• Excellent interpersonal and communication skills.
• Strong organizational and prioritization abilities.

Responsibilities

• Lead PV QA workflows and ensure GVP compliance.
• Support audits and inspections with traceable records.
• Drive continuous improvement of PV quality processes.
• Coordinate deviations and CAPA investigations.
• Provide training oversight and LMS management.
• Collaborate with PV Operations and CGSDCI.

Skills

Fluent English

Interpersonal skills

Organizational skills

Pharmacovigilance

Team collaboration

Tools

PV systems

Database management

Job description

Celltrion Inc in the Philippines seeks a Quality Assurance Specialist to strengthen the PV Quality Management System and serve as a subject-matter expert in PV QA. You will partner with PV Operations to prevent, detect, and correct quality issues while driving continuous improvement aligned with GVP, ICH, EMA, and FDA expectations.

The role covers QMS management, training oversight in ELMS, audits & inspections support, deviation & CAPA leadership, and cross-functional collaboration to maintain