Quality & Pharmacovigilance (QA & PV) Specialist

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

Jora Malaysia will close on 9th September 2026. Thank you for being with us, we are cheering you on as you continue your career journey.

Quality & Pharmacovigilance (QA & PV) Specialist

1) Quality Management System Responsibilities:

• Implement, maintain and improve the local QMS for Malaysia and Singapore in alignment with corporate quality standards and local regulatory requirements.
• Perform local impact & gap assessments following distribution of Corporate Quality Standards.
• Draft, review, update and manage SOPs, policies, work instructions, forms and quality records.
• Monitor implementation of quality processes and ensure adherence across relevant functions.
• Establish and maintain a self-inspection and internal audit programme.
• Monitor quality metrics and KPI reporting and elevate quality compliance risks to management as appropriate.
• Management of Change Controls.
• Manage deviations, CAPAs, quality risk assessments and effectiveness checks in accordance with corporate and local procedures.
• Assist in the preparation, coordination, and support of internal and external GxP audits/inspections, including audit readiness activities, document retrieval, response coordination, CAPA follow-up and monitor effectiveness.
• Ensure proper archival and retention of quality records in accordance with local regulatory requirements and company procedures.

2) Pharmacovigilance Responsibilities:

• Act as nominated Deputy Local Responsible Person for Pharmacovigilance (RPPV) for Malaysia and Singapore.
• Management of Pharmacovigilance (PV) Cases whatever the sources and perform local literature screening as per internal procedures.
• PSMF maintenance as applicable as per local regulatory requirement including collection, verification and maintenance of PSMF annexes and supporting documentation.
• Ensure the implementation and maintenance of a local Pharmacovigilance Quality System in accordance with Global processes and local regulatory authorities requirements.
• Assist in maintaining oversight of PV interfaces and perform periodic reconciliation activities with relevant functions and service providers to ensure complete capture and reporting of safety information.
• Support implementation and follow-up of Risk Management Plans (RMPs) and additional Risk Minimisation Measures (RMMs), including maintenance of traceability records.
• Coordinate PV training for affiliate employees, distributors and service providers and maintain training records and compliance metrics.
• Perform local pharmacovigilance regulatory intelligence activities and assess impact of new or revised PV requirements.
• Ensure that PV documents are archived in accordance with local regulatory requirements and data protection rules, as applicable.