Quality & Pharmacovigilance Pro - Risk & Compliance

Servier; Selangor; On-site; MYR 90,000 - 130,000; Full time

Job summary

Servier Malaysia is seeking a QA & PV Specialist to drive local QMS and pharmacovigilance activities for Malaysia and Singapore. You will implement and maintain quality systems, draft SOPs and manage CAPA processes, deviations and risk assessments.

The role also includes PV oversight as Deputy Local Responsible Person and ensuring regulatory alignment. You will coordinate audits, training, and PV documentation, ensuring data protection and adherence to local requirements while supporting

Qualifications

• Experience implementing local QMS aligned with corporate standards.
• Knowledge of Malaysia and Singapore regulatory requirements.
• Draft, review and manage SOPs, policies and quality records.
• Support internal and external GxP audits and inspections.
• Coordinate PV processes and regulatory activities.

Responsibilities

• Implement, maintain and improve the local QMS for Malaysia & Singapore.
• Draft and manage SOPs, forms and quality records.
• Monitor quality processes and KPI reporting.
• Manage deviations, CAPAs and risk assessments.
• Serve as Deputy Local Responsible Person for PV for Malaysia & Singapore.
• Maintain PV systems, training records and data protection compliance.

Skills

QMS Implementation

Pharmacovigilance

GxP Audits

CAPA Management

Regulatory Compliance

Tools

Audit Tools

Job description

Servier Malaysia is seeking a QA & PV Specialist to drive local QMS and pharmacovigilance activities for Malaysia and Singapore. You will implement and maintain quality systems, draft SOPs and manage CAPA processes, deviations and risk assessments.

The role also includes PV oversight as Deputy Local Responsible Person and ensuring regulatory alignment. You will coordinate audits, training, and PV documentation, ensuring data protection and adherence to local requirements while supporting