Quality & Pharmacovigilance (QA & PV) Specialist

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