Quality & Pharmacovigilance (QA & PV) Specialist (Petaling Jaya, Selangor, MY)

We are one of the largest private French pharmaceutical companies with a worldwide workforce of 22,000, including 3,000 in Research & Development. Being a research-based multinational phamaceutical company, we believe in contributing to medical progress through research, to satisfy both the needs of the physicians prescribing our products, the patients benefiting from them and to ensure our employees find fulfillment in, and by, their work.

Servier Malaysia is seeking highly motivated individuals who are committed to excellence and embody strong values of honesty and integrity.

Job Description

Activities & Responsibilities:

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 escalate 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.

Candidate Profile

Qualifications/ Skills

Bachelor's Degree in Pharmacy, Pharmaceutical Sciences, Life Sciences, Chemistry, Biotechnology or related discipline.

Minimum 3 years experience in pharmaceutical Quality Assurance, Pharmacovigilance Quality or related GxP functions.

Practical experience in QMS implementation and maintenance including management of deviations, CAPAs, change controls and quality risk assessments.

Experience supporting or participating in Health Authority inspections and internal audits. Familiar with NPRA & HSA regulatory requirements.

Good verbal and written communication skills

Strong organisational and project management capabilities.

Proficient in using digital tools (eg Microsoft Office, Visio)

High level of integrity, accountability and professionalism

This is a 12-month fixed-term contract position.

Whatever your area of expertise, your work within the Servier Group helps advance therapeutic progress for the benefit of patients. You will be part of teams recognised for their scientific excellence and reach your full potential in a professional environment that encourages you to develop yourself. Tailor-made onboarding journeys, mobility opportunities, quality trainings, responsible management, team spirit... All this and more in a workplace focused on your well-being.

At Servier, we are committed to therapeutic progress to serve patient needs. We put the diversity of our employees as a source of richness for the fulfillment of this vocation.

]]>